[ { "trial": "T018", "source": "library", "arms": { "Ketamine group": { "randomized": null, "analysed": "327" }, "Control group (no injection; PCIA without ketamine)": { "randomized": null, "analysed": "327" } }, "depression": [ { "measure": "EPDS (PPD at 6-8 weeks; postpartum blues at 4-6 days, EPDS > 9)", "day": -1, "form": "count", "definition": "EPDS > 9 (antenatal depressive symptom, assessed at gestational weeks 36-40)", "location": "Table 1, 'Antenatal depressive symptom: Yes'", "values": { "Ketamine group": { "events": "122", "n": null }, "Control group (no injection; PCIA without ketamine)": { "events": "116", "n": null } } }, { "measure": "EPDS (PPD at 6-8 weeks; postpartum blues at 4-6 days, EPDS > 9)", "day": 4, "form": "mean_sd", "location": "Table 2, '4 days postpartum: EPDS score'", "values": { "Ketamine group": { "mean": "4.27", "sd": "3.8", "n": "327" }, "Control group (no injection; PCIA without ketamine)": { "mean": "5.17", "sd": "4.6", "n": "327" } } }, { "measure": "EPDS (PPD at 6-8 weeks; postpartum blues at 4-6 days, EPDS > 9)", "day": 4, "form": "count", "definition": "EPDS > 9 (postpartum blues)", "location": "Table 2, '4 days postpartum: Prevalence of postpartum blues'", "values": { "Ketamine group": { "events": "39", "n": "327" }, "Control group (no injection; PCIA without ketamine)": { "events": "60", "n": "327" } } }, { "measure": "EPDS (PPD at 6-8 weeks; postpartum blues at 4-6 days, EPDS > 9)", "day": 42, "form": "mean_sd", "location": "Table 2, '42 days postpartum: EPDS score'", "values": { "Ketamine group": { "mean": "4.90", "sd": "4.3", "n": "327" }, "Control group (no injection; PCIA without ketamine)": { "mean": "5.55", "sd": "5.0", "n": "327" } } }, { "measure": "EPDS (PPD at 6-8 weeks; postpartum blues at 4-6 days, EPDS > 9)", "day": 42, "form": "count", "definition": "EPDS > 9 (postpartum depression)", "location": "Table 2, '42 days postpartum: Prevalence of postpartum depression'", "values": { "Ketamine group": { "events": "42", "n": "327" }, "Control group (no injection; PCIA without ketamine)": { "events": "64", "n": "327" } } } ], "pain": [ { "measure": "NRS postoperative pain", "day": 1, "form": "mean_sd", "location": "Results 3.3 (Secondary outcomes), text", "values": { "Ketamine group": { "mean": "1.85", "sd": null, "n": null }, "Control group (no injection; PCIA without ketamine)": { "mean": "1.77", "sd": null, "n": null } } }, { "measure": "NRS postoperative pain", "day": 2, "form": "mean_sd", "location": "Results 3.3 (Secondary outcomes), text", "values": { "Ketamine group": { "mean": "1.20", "sd": null, "n": null }, "Control group (no injection; PCIA without ketamine)": { "mean": "1.22", "sd": null, "n": null } } } ], "adverse_events": [ { "window": "intraoperative", "values": { "Ketamine group": { "dizziness": "18", "hallucination": "4", "visual": "11" }, "Control group (no injection; PCIA without ketamine)": { "dizziness": "14" } } } ], "blinding_check": null, "enrollment": { "start": "2014-08", "end": "2016-12" }, "registration": { "number": "ChiCTR-ROC-17,012,944", "date": null }, "note": "Randomized per arm not printed: 702 recruited, 654 'included' (Fig. 1 flow chart not reproduced); all 654 completed follow-up and Table 2's 'Number' row gives 327 per arm, used as analysed and as n for Table 2 rows. Table 2 labels the times '4 days postpartum' and '42 days postpartum' (Methods: follow-up at 4-6 days and 6-8 weeks); days recorded as printed (4, 42). Table 2 footnote: values are mean ± SD or number (%). Day -1 count is Table 1's antenatal EPDS > 9 (gestational weeks 36-40); Table 1 prints no column n and the control percentage is garbled as '35,.5'. NRS: text gives only means for the first and second postoperative days, no SD or n. Adverse events are those 'during the operation'; ketamine 'nystagmus in 11 (3.4%)' coded as visual. Text says 'No other adverse reactions were observed in the control group' and 'During PCIA time, no obvious adverse reactions were found in both groups', i.e. no hallucination or nystagmus in control and none postoperatively, but no zeros are printed, so they are left out. Enrollment period is from Methods 2.1 (Results do not state it). Registration printed as 'ChiCTR-ROC-17,012,944' (commas as printed), no registration date; ethics approval February 20, 2014." }, { "trial": "T031", "source": "fulltext", "arms": { "Ketamine group": { "randomized": "33", "analysed": "32" }, "Placebo group": { "randomized": "33", "analysed": "32" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "median_iqr", "location": "Table 1, 'Depression score (point)'", "values": { "Ketamine group": { "median": "12", "q1": "10", "q3": "13", "n": "32" }, "Placebo group": { "median": "11", "q1": "10", "q3": "12", "n": "32" } } }, { "measure": "EPDS", "day": 2, "form": "median_iqr", "location": "Table 3, 'Depression score at 48 h (point)'", "values": { "Ketamine group": { "median": "9", "q1": "6", "q3": "13", "n": "32" }, "Placebo group": { "median": "8", "q1": "6", "q3": "10", "n": "32" } } }, { "measure": "EPDS", "day": 2, "form": "change_median_iqr", "location": "Table 3, exploratory analysis, 'Change from baseline depression score (point): At 48 h'", "values": { "Ketamine group": { "median": "-4", "q1": "-5", "q3": "0", "n": "32" }, "Placebo group": { "median": "-2", "q1": "-4", "q3": "-1", "n": "32" } } }, { "measure": "EPDS", "day": 42, "form": "median_iqr", "location": "Table 3, 'Depression score at 42 days (point)'", "values": { "Ketamine group": { "median": "10", "q1": "7", "q3": "12", "n": "32" }, "Placebo group": { "median": "9", "q1": "7", "q3": "11", "n": "32" } } }, { "measure": "EPDS", "day": 42, "form": "count", "definition": "EPDS ≥ 10", "location": "Table 3, 'Depression score ≥10 at 42 days'", "values": { "Ketamine group": { "events": "18", "n": "32" }, "Placebo group": { "events": "14", "n": "32" } } }, { "measure": "EPDS", "day": 42, "form": "change_median_iqr", "location": "Table 3, exploratory analysis, 'Change from baseline depression score (point): At 42 days'", "values": { "Ketamine group": { "median": "-2", "q1": "-4", "q3": "0", "n": "32" }, "Placebo group": { "median": "-2", "q1": "-5", "q3": "-1", "n": "32" } } } ], "pain": [ { "measure": "NRS at rest", "day": 1, "form": "median_iqr", "location": "Table 3, 'Numeric rating scale of pain at rest: At 24 h'", "values": { "Ketamine group": { "median": "4", "q1": "3", "q3": "5", "n": "32" }, "Placebo group": { "median": "4", "q1": "3", "q3": "4", "n": "32" } } } ], "adverse_events": [ { "window": "intraoperative", "values": { "Ketamine group": { "hallucination": "1", "dizziness": "5", "visual": "3" }, "Placebo group": { "hallucination": "0", "dizziness": "3", "visual": "0" } } }, { "window": "postoperative", "values": { "Ketamine group": { "nightmare": "0" }, "Placebo group": { "nightmare": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2017-11-23", "end": "2018-05-14" }, "registration": { "number": "NCT03336541", "date": "08/11/2017" }, "note": "66 randomized (33/33); one per arm withdrew consent, so efficacy analyses (ITT and per-protocol) have 32/32 and the safety analysis (Table 5) 33/33. EPDS baseline was taken the day before surgery (Table 1, median (IQR)). Table 3 footnote says 'mean ± SD, n (%) or median (interquartile range)'; the text confirms depression scores are median (IQR). Table 3 also prints Hodges-Lehmann median differences (48 h: 1 (-1, 3); 42 days: 1 (-1, 2)) and RR 1.29 (0.78, 2.12) for EPDS ≥10, not recorded since arm values are given; Table 4 gives regression results. Minus signs printed as U+2212 are recorded as '-'. Pain: NRS at rest at 4 h, 8 h and 42 days left out (outside the day 1/day 2 windows). Adverse events from Table 5: 'Diplopia' coded as visual. Table 5 also prints a composite 'Dissociative symptoms' 10 (30.3%) vs 3 (9.1%), which the text defines as hallucination, dizziness, diplopia and hypertonia, so it is not coded as dissociation; hypertonia 1 vs 0, somnolence 4 vs 0 and sedation 5 vs 0 not coded. Enrollment is the Results' eligibility-assessment window; last follow-up June 25, 2018. Registration date printed '08/11/2017' (format not stated; the ethics approval date is printed the same way)." }, { "trial": "T033", "source": "fulltext", "arms": { "Group L (low dose)": { "randomized": null, "analysed": "38" }, "Group M (middle dose)": { "randomized": null, "analysed": "40" }, "Group H (high dose)": { "randomized": null, "analysed": "39" }, "Group C (control)": { "randomized": null, "analysed": "39" } }, "depression": [ { "measure": "Edinburgh Postpartum Depression Scale (EPDS)", "day": 7, "form": "count", "definition": "PPD by EPDS (cutoff not stated)", "location": "Table 3, 'Occurrence of PPD: 1 week'", "values": { "Group L (low dose)": { "events": "5", "n": "38" }, "Group M (middle dose)": { "events": "0", "n": "40" }, "Group H (high dose)": { "events": "0", "n": "39" }, "Group C (control)": { "events": "12", "n": "39" } } }, { "measure": "Edinburgh Postpartum Depression Scale (EPDS)", "day": 42, "form": "count", "definition": "PPD by EPDS (cutoff not stated)", "location": "Table 3, 'Occurrence of PPD: 6 weeks'", "values": { "Group L (low dose)": { "events": "7", "n": "38" }, "Group M (middle dose)": { "events": "2", "n": "40" }, "Group H (high dose)": { "events": "1", "n": "39" }, "Group C (control)": { "events": "14", "n": "39" } } } ], "pain": [ { "measure": "effective PCIA presses within 48 h", "day": 2, "form": "mean_sd", "location": "Table 2, 'Effective press (times)'", "values": { "Group L (low dose)": { "mean": "4.1", "sd": "0.8", "n": "38" }, "Group M (middle dose)": { "mean": "2.9", "sd": "0.7", "n": "40" }, "Group H (high dose)": { "mean": "1.6", "sd": "0.6", "n": "39" }, "Group C (control)": { "mean": "5.4", "sd": "1.0", "n": "39" } } }, { "measure": "total sufentanil consumption within 48 h", "day": 2, "form": "mean_sd", "location": "Table 2, 'Consumption of sufentanil (μg)'", "values": { "Group L (low dose)": { "mean": "66.8", "sd": "5.1", "n": "38" }, "Group M (middle dose)": { "mean": "63.4", "sd": "3.8", "n": "40" }, "Group H (high dose)": { "mean": "60.6", "sd": "1.2", "n": "39" }, "Group C (control)": { "mean": "72.0", "sd": "4.4", "n": "39" } } }, { "measure": "rescue tramadol within 48 h", "day": 2, "form": "count", "definition": "rescue analgesia (tramadol 50 mg i.v.) within 48 h", "location": "Table 2, 'Rescue analgesia [n (%)]'", "values": { "Group L (low dose)": { "events": "2", "n": "38" }, "Group M (middle dose)": { "events": "2", "n": "40" }, "Group H (high dose)": { "events": "1", "n": "39" }, "Group C (control)": { "events": "9", "n": "39" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Group L (low dose)": { "nightmare": "0", "visual": "0" }, "Group M (middle dose)": { "nightmare": "0", "visual": "0" }, "Group H (high dose)": { "nightmare": "0", "visual": "0" }, "Group C (control)": { "nightmare": "0", "visual": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2021-05-02", "end": "2021-12-31" }, "registration": { "number": "ChiCTR2200060387", "date": "April 7, 2021" }, "note": "Per-arm randomized numbers are not printed: 160 enrolled and randomized to 4 groups (Methods also says 'Sixty samples for each group were designed'); 4 excluded after randomization (1 in C, 2 in L, 1 in H), 156 analysed, with analysed n from Table 1-3 row labels. PPD at 1 and 6 weeks is by EPDS with no cutoff stated. Group C's 1-week PPD is printed '12 (30.1)', which does not match 12/39; events copied as printed. Table 2 values are mean ± SD (effective presses, sufentanil μg) and n (%) (rescue analgesia), all within 48 h after surgery. Adverse events (Table 3) were recorded within 48 hours after surgery; nightmares and diplopia (coded as visual) were 0 (0) in all four groups. Enrollment period is from Methods 2.4 (Results do not state it). Registration printed as 'ChiCTR2200060387 on April 7, 2021'; the ID's '22' prefix is the form ChiCTR uses for 2022 registrations, so the date may be an error." }, { "trial": "T034", "source": "fulltext", "arms": { "SC group": { "randomized": "8", "analysed": "8" }, "IV group": { "randomized": "8", "analysed": "8" }, "Placebo group": { "randomized": "7", "analysed": "7" } }, "depression": [ { "measure": "Edinburgh Postpartum Depression Scale (EPDS)", "day": -1, "form": "mean_sd", "location": "Table 1, 'Pre-operative screening: Depression (EPDS)'", "values": { "SC group": { "mean": "6.25", "sd": "6.27", "n": "8" }, "IV group": { "mean": "5", "sd": "4.78", "n": "8" }, "Placebo group": { "mean": "8.29", "sd": "4.72", "n": "7" } } } ], "pain": [ { "measure": "opioid consumption first 48 h (oral MME)", "day": 2, "form": "mean_sd", "location": "Results, 'Postpartum mood, surgical site pain, opioid consumption' paragraph", "values": { "SC group": { "mean": "68.4", "sd": null, "n": null }, "IV group": { "mean": "67.0", "sd": null, "n": null }, "Placebo group": { "mean": "88.6", "sd": null, "n": null } } } ], "adverse_events": [ { "window": "intraoperative", "values": { "SC group": { "hallucination": "0", "visual": "1", "dizziness": "1", "any_ae": "6" }, "IV group": { "hallucination": "0", "visual": "3", "dizziness": "3", "any_ae": "6" }, "Placebo group": { "hallucination": "0", "visual": "1", "dizziness": "1", "any_ae": "7" } } } ], "blinding_check": null, "enrollment": { "start": "2020-12", "end": "2021-08" }, "registration": { "number": "NCT04227704", "date": "14/01/2020" }, "note": "25 consented, 2 withdrawn before the intervention; 'Eight women were allocated to each of the intervention groups while seven women were allocated to placebo control' (recorded as randomized; Fig. 1 not reproduced). Analysed is the n of Tables 1 and 2; full 6-week depression data were obtained for 18/23 overall, not given by arm. Post-delivery EPDS (days 1, 2, 21, 42) and surgical site pain NRS are shown only as graphs (Fig. 2), so not extracted; 8 women (34.8%) screened positive (EPDS > 12) at least once postpartum, cohort-wide only. Baseline EPDS is the pre-operative screening on the day of surgery, mean (SD). Opioid consumption: text gives only mean MME for the first 48 h, no SD or n. Adverse effects (Table 2) are graded mild/moderate/severe; for dizziness and blurred vision only the 'Mild' row is non-zero (moderate and severe 0 (0)), so the mild counts are recorded. 'visual' is the blurred vision row; diplopia is a separate row (mild 0/1/1, others 0) and nystagmus is 0 in all arms, overlap unknown. Hallucination is from the combined row 'Euphoria, Amnesia, Hallucinations, Nystagmus' 0 (0) in every arm. any_ae is 'Self-reported AE incidence'; hemodynamic AE incidence (3/3/2) is separate. Window is not labelled in Table 2; coded intraoperative because its rows match the Methods' list of intraoperative adverse effects and the text calls the shivering difference intraoperative. Anxiety (mild 0/1/2, moderate 0/0/1) not coded. Enrollment period is from Methods (Results do not state it)." }, { "trial": "T040", "source": "fulltext", "arms": { "Ketamine group": { "randomized": "20", "analysed": "20" }, "Placebo (saline) group": { "randomized": "20", "analysed": "20" } }, "depression": [ { "measure": "MADRS", "day": -1, "form": "mean_sd", "location": "Extended Data Table 1, 'Day 0 (pre-infusion)'", "values": { "Ketamine group": { "mean": "25.1", "sd": "8.3", "n": "20" }, "Placebo (saline) group": { "mean": "29.9", "sd": "7.0", "n": "19" } } }, { "measure": "MADRS", "day": -1, "form": "mean_sd", "location": "Table 1, 'MADRS total score' at the screening visit (mean 5.1 days before surgery)", "values": { "Ketamine group": { "mean": "27.7", "sd": "7.8", "n": "20" }, "Placebo (saline) group": { "mean": "30.6", "sd": "6.3", "n": "20" } } }, { "measure": "MADRS", "day": 1, "form": "mean_sd", "location": "Extended Data Table 1, 'Day 1'", "values": { "Ketamine group": { "mean": "12.7", "sd": "7.6", "n": "20" }, "Placebo (saline) group": { "mean": "16.4", "sd": "10.0", "n": "19" } } }, { "measure": "MADRS", "day": 1, "form": "change_mean_sd", "location": "Results, Outcomes, second paragraph (change from day 0 to day 1)", "values": { "Ketamine group": { "mean": "-12.4", "sd": "9.2", "n": null }, "Placebo (saline) group": { "mean": "-14.7", "sd": "9.0", "n": null } } }, { "measure": "MADRS", "day": 2, "form": "mean_sd", "location": "Extended Data Table 1, 'Day 2'", "values": { "Ketamine group": { "mean": "15.1", "sd": "11.1", "n": "19" }, "Placebo (saline) group": { "mean": "17.5", "sd": "11.5", "n": "20" } } }, { "measure": "MADRS", "day": 3, "form": "mean_sd", "location": "Extended Data Table 1, 'Day 3'", "values": { "Ketamine group": { "mean": "17.0", "sd": "10.5", "n": "19" }, "Placebo (saline) group": { "mean": "17.2", "sd": "12.0", "n": "20" } } }, { "measure": "MADRS", "day": 5, "form": "mean_sd", "location": "Extended Data Table 1, 'Day 5'", "values": { "Ketamine group": { "mean": "16.9", "sd": "8.0", "n": "19" }, "Placebo (saline) group": { "mean": "16.9", "sd": "10.1", "n": "18" } } }, { "measure": "MADRS", "day": 7, "form": "mean_sd", "location": "Extended Data Table 1, 'Day 7'", "values": { "Ketamine group": { "mean": "15.9", "sd": "9.2", "n": "18" }, "Placebo (saline) group": { "mean": "18.5", "sd": "10.8", "n": "19" } } }, { "measure": "MADRS", "day": 14, "form": "mean_sd", "location": "Extended Data Table 1, 'Day 14'", "values": { "Ketamine group": { "mean": "16.9", "sd": "10.0", "n": "19" }, "Placebo (saline) group": { "mean": "16.2", "sd": "12.5", "n": "19" } } }, { "measure": "HADS score", "day": -1, "form": "mean_sd", "location": "Extended Data Table 1, 'HADS total score: Day 0 (pre-infusion)'", "values": { "Ketamine group": { "mean": "22.9", "sd": "4.2", "n": "20" }, "Placebo (saline) group": { "mean": "24.6", "sd": "5.6", "n": "19" } } }, { "measure": "HADS score", "day": -1, "form": "mean_sd", "location": "Table 1, 'HADS: Total score' at the screening visit", "values": { "Ketamine group": { "mean": "24.6", "sd": "6.0", "n": "20" }, "Placebo (saline) group": { "mean": "24.7", "sd": "5.7", "n": "20" } } }, { "measure": "HADS score", "day": 1, "form": "mean_sd", "location": "Extended Data Table 1, 'HADS total score: Day 1'", "values": { "Ketamine group": { "mean": "17.8", "sd": "6.6", "n": "20" }, "Placebo (saline) group": { "mean": "19.9", "sd": "5.5", "n": "19" } } }, { "measure": "HADS score", "day": 2, "form": "mean_sd", "location": "Extended Data Table 1, 'HADS total score: Day 2'", "values": { "Ketamine group": { "mean": "18.8", "sd": "7.5", "n": "18" }, "Placebo (saline) group": { "mean": "21.2", "sd": "5.9", "n": "20" } } }, { "measure": "HADS score", "day": 3, "form": "mean_sd", "location": "Extended Data Table 1, 'HADS total score: Day 3'", "values": { "Ketamine group": { "mean": "19.3", "sd": "6.3", "n": "19" }, "Placebo (saline) group": { "mean": "20.8", "sd": "5.4", "n": "20" } } }, { "measure": "HADS score", "day": 5, "form": "mean_sd", "location": "Extended Data Table 1, 'HADS total score: Day 5'", "values": { "Ketamine group": { "mean": "18.3", "sd": "4.8", "n": "19" }, "Placebo (saline) group": { "mean": "18.9", "sd": "7.3", "n": "19" } } }, { "measure": "HADS score", "day": 7, "form": "mean_sd", "location": "Extended Data Table 1, 'HADS total score: Day 7'", "values": { "Ketamine group": { "mean": "18.4", "sd": "5.3", "n": "16" }, "Placebo (saline) group": { "mean": "19.6", "sd": "8.1", "n": "19" } } }, { "measure": "HADS score", "day": 14, "form": "mean_sd", "location": "Extended Data Table 1, 'HADS total score: Day 14'", "values": { "Ketamine group": { "mean": "16.4", "sd": "7.2", "n": "19" }, "Placebo (saline) group": { "mean": "17.2", "sd": "8.5", "n": "19" } } }, { "measure": "HADS depression subscore", "day": -1, "form": "mean_sd", "location": "Table 1, 'HADS: Depression subscore' at the screening visit", "values": { "Ketamine group": { "mean": "12.0", "sd": "3.2", "n": "20" }, "Placebo (saline) group": { "mean": "10.5", "sd": "3.6", "n": "20" } } }, { "measure": "PHQ-8 total score", "day": -1, "form": "mean_sd", "location": "Table 1, 'PHQ-8 total score' at the screening visit", "values": { "Ketamine group": { "mean": "15.8", "sd": "3.6", "n": "20" }, "Placebo (saline) group": { "mean": "15.8", "sd": "3.8", "n": "20" } } } ], "pain": [ { "measure": "cumulative and daily opioid use (MME)", "day": 1, "form": "mean_sd", "location": "Extended Data Table 2, 'Average Daily Inpatient Opioid Use, in MME: Day 1'", "values": { "Ketamine group": { "mean": "81.6", "sd": "59.6", "n": "14" }, "Placebo (saline) group": { "mean": "69.2", "sd": "62.2", "n": "16" } } }, { "measure": "cumulative and daily opioid use (MME)", "day": 2, "form": "mean_sd", "location": "Extended Data Table 2, 'Average Daily Inpatient Opioid Use, in MME: Day 2'", "values": { "Ketamine group": { "mean": "83.3", "sd": "65.2", "n": "8" }, "Placebo (saline) group": { "mean": "77.6", "sd": "71.3", "n": "13" } } } ], "adverse_events": [], "blinding_check": { "who": "participants", "day": 14, "values": null, "overall": { "correct": "36.8%", "kappa": "0.33", "n_per_arm": "19", "guessed_ketamine": "16", "guessed_placebo": "10", "dont_know": "12" }, "location": "Results, Outcomes, third paragraph; by-arm distribution shown only as percentages in Figure 2B (graph); Extended Data Figure 1 caption gives guess groups n=17/10/11" }, "enrollment": { "start": "2020-02-19", "end": "2022-08-18" }, "registration": null, "note": "40 randomized (20/20, after 5 open-label pilot patients not reported); ITT analysis of the primary outcome with n=20 per arm. Two baselines per scale: the Day 0 pre-infusion assessment on the day of surgery (Extended Data Table 1, listed first) and the screening visit a mean of 5.1 days before surgery (Table 1); both coded day -1. Post-infusion days equal postoperative days (infusion given during surgery). The day 1 change from day 0 (-12.4 SD 9.2 vs -14.7 SD 9.0) is from the text, no n given. Extended Data Table 1 also gives clinical response (>=50% MADRS reduction from screening) and remission (MADRS <=12) as n/N by day (e.g. remission day 1: 10/20 vs 7/20); not coded as counts because they count improved participants, not participants with depression. Table 1 also gives the HADS anxiety subscore (not coded). Table 3 gives mixed-model estimates only. Pain: BPI-SF is reported only at screening and day 14 (average pain 4.8 SD 1.5 vs 3.7 SD 2.0), outside day 1/2. Opioid use day 1/2 is average daily inpatient MME among patients hospitalised the whole day; cumulative opioid consumption is only in Figure 2E (median, IQR graph). No psychotomimetic adverse events are reported; one death in the ketamine group 5 days post-infusion (cardiac arrest at home) and one placebo reoperation on day 3. Blinding: text gives guess groups n=16 ketamine / 10 placebo / 12 don't know, but the Extended Data Figure 1 caption gives 17/10/11. No trial registration number appears in the text. Minus signs printed as U+2212 are recorded as '-'." }, { "trial": "T064", "source": "fulltext", "arms": { "Ketamine": { "randomized": "152", "analysed": "129" }, "Placebo (0.9% saline)": { "randomized": "149", "analysed": "132" } }, "depression": [ { "measure": "HADS depression score (>= 8)", "day": -1, "form": "count", "definition": "HADS Depression score of 8 or above", "location": "Table 1, 'Symptoms of depression (HADS Depression score of 8 or above)', denominators from footnote ††", "values": { "Ketamine": { "events": "21", "n": "136" }, "Placebo (0.9% saline)": { "events": "28", "n": "132" } } }, { "measure": "HADS depression score (>= 8)", "day": 7, "form": "count", "definition": "HADS Depression score of 8 or above", "location": "Table 2, 'Seven days following surgery: Symptoms of depression', denominators from footnote ***", "values": { "Ketamine": { "events": "19", "n": "124" }, "Placebo (0.9% saline)": { "events": "27", "n": "128" } } }, { "measure": "HADS depression score (>= 8)", "day": 90, "form": "count", "definition": "HADS Depression score of 8 or above", "location": "Table 2, 'Ninety days following surgery: Symptoms of depression', denominators from footnote ††", "values": { "Ketamine": { "events": "11", "n": "124" }, "Placebo (0.9% saline)": { "events": "24", "n": "113" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "values": { "Ketamine": { "psychiatric_any": "4" }, "Placebo (0.9% saline)": { "psychiatric_any": "5" } } }, { "window": "overall", "values": { "Ketamine": { "any_ae": "33" }, "Placebo (0.9% saline)": { "any_ae": "34" } } } ], "blinding_check": null, "enrollment": { "start": "2017-03-20", "end": "2019-05-28" }, "registration": { "number": "NCT02892916", "date": "September 2016" }, "note": "Randomized 152 ketamine / 149 placebo (abstract); 9 withdrew consent, ITT 149/143 (Results, Table 1 and Table 2 column heads); 'All analyses were performed on a modified intention-to-treat (mITT) basis', mITT 129/132, recorded as analysed. Depression is reported only as counts with HADS-D >= 8; n per time is the table footnote denominator (Table 2's 90-day column heads say n = 125/115, but footnote †† gives 124/113, which matches the printed percentages). Table 2 ORs (adjusted for MoCA, age and baseline): day 7 0.71 [0.30-1.70], day 90 0.34 [0.13-0.86]. Three months coded as day 90 (Table 2 says 'Ninety days following surgery'). Pain (VAS at rest, cumulative opioids, DN4) is reported only in supplementary Tables S6-S7, not in this text; the text says only that pain at rest was lower in PACU with ketamine. Adverse events: 'postoperative psychiatric adverse events during the initial seven days' 4 (2.68%) of 149 vs 5 (3.5%) of 143 (Methods: hallucinations collected, nightmares not), coded psychiatric_any; 'perioperative adverse events' 33 [23.1%] ketamine vs 34 [23.4%] placebo coded any_ae with window overall (their percentages do not match the ITT denominators). Delirium (CAM) 6 (4.14%) vs 9 (6.34%) over 7 days not coded as agitation. Primary outcome changed by amendment on 02/19/2018 (93 enrolled), registered May 2019; IRB reference '#2016-000691-16'." }, { "trial": "T073", "source": "registry", "arms": { "Epidural morphine 3 mg + IV saline": { "randomized": "26", "analysed": null }, "Epidural morphine 3 mg + IV ketamine 0.3 mg/kg": { "randomized": "26", "analysed": null } }, "depression": [ { "measure": "Edinburgh Postnatal Depression Scale (presence of postpartum depression)", "day": 7, "form": "mean_range", "location": "Posted results, secondary outcome 'Presence of Postpartum Depression', time frame 1 week after delivery ('MEAN Full Range')", "values": { "Epidural morphine 3 mg + IV saline": { "mean": "7.0", "min": "4.7", "max": "9.4", "n": "19" }, "Epidural morphine 3 mg + IV ketamine 0.3 mg/kg": { "mean": "6.7", "min": "4.9", "max": "9.4", "n": "24" } } }, { "measure": "Edinburgh Postnatal Depression Scale (presence of postpartum depression)", "day": 42, "form": "mean_range", "location": "Posted results, secondary outcome 'Presence of Postpartum Depression', time frame 6 weeks after delivery ('MEAN Full Range')", "values": { "Epidural morphine 3 mg + IV saline": { "mean": "4.7", "min": "2.8", "max": "6.6", "n": "19" }, "Epidural morphine 3 mg + IV ketamine 0.3 mg/kg": { "mean": "4.8", "min": "3.3", "max": "6.3", "n": "22" } } }, { "measure": "PROMIS-29 depressive symptoms", "day": 90, "form": "mean_range", "location": "Posted results, secondary outcome 'Promis 29 Profile (Depressive Symptoms Question Only)', time frame 3 month, T score ('MEAN Full Range')", "values": { "Epidural morphine 3 mg + IV saline": { "mean": "43", "min": "40.9", "max": "45.2", "n": "20" }, "Epidural morphine 3 mg + IV ketamine 0.3 mg/kg": { "mean": "43.6", "min": "41.2", "max": "45.9", "n": "21" } } } ], "pain": [ { "measure": "McGill Pain Questionnaire (perineal pain)", "day": 1, "form": "mean_range", "location": "Posted results, secondary outcome 'Perineal Pain', time frame Day 1 after delivery (MPQ, 'MEAN Full Range')", "values": { "Epidural morphine 3 mg + IV saline": { "mean": "10.4", "min": "7.9", "max": "12.9", "n": "23" }, "Epidural morphine 3 mg + IV ketamine 0.3 mg/kg": { "mean": "12.9", "min": "10.0", "max": "15.8", "n": "24" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Epidural morphine 3 mg + IV saline": { "any_ae": "14" }, "Epidural morphine 3 mg + IV ketamine 0.3 mg/kg": { "any_ae": "13" } } } ], "blinding_check": null, "enrollment": null, "registration": { "number": "NCT03470675", "date": null }, "note": "Registry posted results. The 'Epidural saline + IV saline' arm (role other) is left out. Randomized is the participant flow 'STARTED' count (26/26); 'COMPLETED' is 17 control / 21 ketamine; analysed n differs by outcome and time, so given per entry and no arm-wide analysed number. The registry labels every secondary result 'MEAN Full Range' (the primary VRS result 'MEAN Inter-Quartile Range'); recorded as form 'mean_range' with lowerLimit/upperLimit as min/max as labelled, but they are probably 95% CIs: they sit near-symmetrically around the means and are non-integers although EPDS totals are integers, so they cannot be minima and maxima. The EPDS outcome is titled 'Presence of Postpartum Depression' but reports mean scores (0-30). Three months coded as day 90. Pain: only the MPQ at day 1 falls in the day 1/2 window; VRS (1 week, 1 year), MPQ (1 week, 6 weeks, 3 months), BPI current pain and PROMIS-29 pain interference (1 week to 3 months) are left out. Adverse events were collected over 48 hours after delivery: serious 0/26 vs 0/25, other 14/26 vs 13/25 (recorded as any_ae); none is psychotomimetic (hypotension, pruritus, fever, back ache, nausea, vomiting, hives, wound problems). No enrollment dates or registration date in the posted results." }, { "trial": "T086", "source": "fulltext", "arms": { "Esketamine group": { "randomized": null, "analysed": "140" }, "Control group": { "randomized": null, "analysed": "140" } }, "depression": [ { "measure": "EPDS (postpartum depression incidence, >= 10)", "day": -1, "form": "mean_sd", "location": "Table 1, 'Pre-operative EPDS score'", "values": { "Esketamine group": { "mean": "8.9", "sd": "4.0", "n": "140" }, "Control group": { "mean": "9.3", "sd": "4.0", "n": "140" } } }, { "measure": "Prenatal depression", "day": -1, "form": "count", "definition": "prenatal depression (definition not stated)", "location": "Table 1, 'Prenatal depression, n (%)'", "values": { "Esketamine group": { "events": "57", "n": "140" }, "Control group": { "events": "64", "n": "140" } } }, { "measure": "SDS (Self-Rating Depression Scale)", "day": -1, "form": "mean_sd", "location": "Table 1, 'Pre-operative SDS score'", "values": { "Esketamine group": { "mean": "45.8", "sd": "9.0", "n": "140" }, "Control group": { "mean": "45.7", "sd": "10.1", "n": "140" } } }, { "measure": "EPDS (postpartum depression incidence, >= 10)", "day": null, "form": "count", "definition": "EPDS ≥ 10", "location": "Table 2, 'PPD (total), n (%)'", "values": { "Esketamine group": { "events": "41", "n": "140" }, "Control group": { "events": "50", "n": "140" } } } ], "pain": [], "adverse_events": [ { "window": "intraoperative", "values": { "Esketamine group": { "dizziness": "4", "hallucination": "2", "nightmare": "5" }, "Control group": { "dizziness": "0", "hallucination": "0", "nightmare": "0" } } }, { "window": "postoperative", "values": { "Esketamine group": { "dizziness": "1" }, "Control group": { "dizziness": "4" } } } ], "blinding_check": null, "enrollment": { "start": "2022-01-15", "end": "2022-07-30" }, "registration": { "number": "ChiCTR2100050976", "date": "09/09/2021" }, "note": "290 recruited and randomized 1:1; 10 excluded after randomization (2 converted to general anaesthesia, 1 post-partum haemorrhage, 5 lost to follow-up, 2 EPQ L-scale >60), leaving 140 per group (Tables 1, 2, 4); per-arm randomized numbers are not printed (Fig. 1 flow chart not reproduced). The time of the postpartum EPDS assessment is not stated anywhere in the text (baseline scales were taken the day before surgery; the sample size cites a 28% PPD incidence 'on the 3rd day after a caesarean section'; median hospital stay 4 days), so day is null for the PPD (total) count. Table 2 also gives PPD by personality type (subgroups, not coded). 'Prenatal depression' (Table 1) has no stated definition or instrument, so it is coded under the source's name. Pain: NRS at rest and on movement (4-48 h) and severe-pain rates are shown only in Figs 2-3 (graphs); indomethacin use is not reported. Adverse events from Table 4 by its intra-operative and post-operative rows; drowsiness, nausea/vomiting and RSS >3 not coded. Enrollment period is from Methods, Participants (Results do not state it)." }, { "trial": "T108", "source": "fulltext", "arms": { "Esketamine group": { "randomized": null, "analysed": "35" }, "Control group": { "randomized": null, "analysed": "34" } }, "depression": [ { "measure": "HAMD-17", "day": -1, "form": "count", "definition": "HAMD-17 > 7", "location": "Table 2, 'Pre-operation: Yes'", "values": { "Esketamine group": { "events": "10", "n": "35" }, "Control group": { "events": "6", "n": "34" } } }, { "measure": "HAMD-17", "day": 1, "form": "count", "definition": "HAMD-17 > 7", "location": "Table 2, 'POD 1: Yes'", "values": { "Esketamine group": { "events": "18", "n": "35" }, "Control group": { "events": "18", "n": "34" } } }, { "measure": "HAMD-17", "day": 1, "form": "change_median_iqr", "location": "Table 3, 'POD 1' (postoperative minus preoperative score)", "values": { "Esketamine group": { "median": "3", "q1": "1", "q3": "5", "n": "35" }, "Control group": { "median": "3.5", "q1": "1", "q3": "6.25", "n": "34" } } }, { "measure": "HAMD-17", "day": 3, "form": "count", "definition": "HAMD-17 > 7", "location": "Table 2, 'POD 3: Yes'", "values": { "Esketamine group": { "events": "15", "n": "35" }, "Control group": { "events": "16", "n": "34" } } }, { "measure": "HAMD-17", "day": 3, "form": "change_median_iqr", "location": "Table 3, 'POD 3' (postoperative minus preoperative score)", "values": { "Esketamine group": { "median": "1", "q1": "0", "q3": "3", "n": "35" }, "Control group": { "median": "2", "q1": "1", "q3": "5", "n": "34" } } }, { "measure": "HAMD-17", "day": 5, "form": "count", "definition": "HAMD-17 > 7", "location": "Table 2, 'POD 5: Yes'", "values": { "Esketamine group": { "events": "12", "n": "35" }, "Control group": { "events": "11", "n": "34" } } }, { "measure": "HAMD-17", "day": 5, "form": "change_median_iqr", "location": "Table 3, 'POD 5' (postoperative minus preoperative score)", "values": { "Esketamine group": { "median": "0", "q1": "0", "q3": "1", "n": "35" }, "Control group": { "median": "1", "q1": "0", "q3": "2", "n": "34" } } } ], "pain": [ { "measure": "VAS pain", "day": 1, "form": "median_iqr", "location": "Table 4, 'POD 1'", "values": { "Esketamine group": { "median": "3", "q1": "2", "q3": "4", "n": "35" }, "Control group": { "median": "4", "q1": "3", "q3": "5", "n": "34" } } }, { "measure": "VAS pain", "day": 2, "form": "median_iqr", "location": "Table 4, 'POD 2'", "values": { "Esketamine group": { "median": "3", "q1": "2", "q3": "3", "n": "35" }, "Control group": { "median": "3", "q1": "2", "q3": "4", "n": "34" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Esketamine group": { "dizziness": "4", "nightmare": "0", "dissociation": "0" }, "Control group": { "dizziness": "1", "nightmare": "0", "dissociation": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2023-01", "end": "2024-12" }, "registration": { "number": "ChiCTR2200066303", "date": "2022-11-30" }, "note": "80 randomized (Methods planned 40 per group; per-arm randomized numbers not printed, Fig. 1 not reproduced); 5 refused to continue, 3 had the surgical approach changed and 3 were lost to follow-up, leaving 34 control and 35 esketamine analysed. Depression is HAMD-17 > 7 (Table 2, n (%)) at pre-operation, POD 1, 3 and 5; Table 3 gives the change (postoperative minus preoperative score) as median (IQR). Absolute HAMD-17 scores are only in Supplementary Table 2 (not in this text); POD 2 HAMD-17 is not reported despite being planned. Pain: VAS median (IQR) at POD 1 and POD 2 recorded; PACU admission, POD 3 and POD 5 left out (the text also mentions 6 h, which Table 4 lacks). Table 5's total postoperative opioid dose (morphine equivalents, mg, 114.9 ± 23.32 vs 100.9 ± 25.72) and PCIA button presses (9.32 ± 6.48 vs 6.54 ± 4.39) have no stated time window (PCIA ran more than 72 h), so they are not assigned to day 1 or 2. Adverse events are postoperative (Table 5): dizziness ('Diziness') yes 1 (2.9) vs 4 (11.4); nightmares and dissociation 0 in both. Enrollment period is the Methods' 'conducted ... between January 2023 and December 2024' (Results do not state it). Registration date printed '2022–11–30', registered prior to enrollment." } ]