[
  {
    "trial": "T017",
    "source": "library",
    "arms": {
      "group D": {
        "randomized": "99",
        "analysed": "95"
      },
      "group KD": {
        "randomized": "99",
        "analysed": "94"
      }
    },
    "depression": [],
    "pain": [
      {
        "measure": "100-mm VAS pain at 1, 6, 24, 48 h (rest or movement not stated)",
        "day": 1,
        "form": "mean_sd",
        "location": "Table 2, row VAS 24 h",
        "values": {
          "group D": {
            "mean": "34.9",
            "sd": "7.7",
            "n": "95"
          },
          "group KD": {
            "mean": "30.9",
            "sd": "6.7",
            "n": "94"
          }
        }
      },
      {
        "measure": "100-mm VAS pain at 1, 6, 24, 48 h (rest or movement not stated)",
        "day": 2,
        "form": "mean_sd",
        "location": "Table 2, row VAS 48 h",
        "values": {
          "group D": {
            "mean": "23.8",
            "sd": "6.3",
            "n": "95"
          },
          "group KD": {
            "mean": "22.8",
            "sd": "5.9",
            "n": "94"
          }
        }
      },
      {
        "measure": "PCA (morphine, ketorolac) consumption over 24 h",
        "day": 1,
        "form": "mean_sd",
        "location": "Table 2, row PCA consumption for 24 after surgery",
        "values": {
          "group D": {
            "mean": "65.3",
            "sd": "5.2",
            "n": "95"
          },
          "group KD": {
            "mean": "61.1",
            "sd": "7.2",
            "n": "94"
          }
        }
      }
    ],
    "adverse_events": [
      {
        "window": "postoperative",
        "values": {
          "group D": {
            "hallucination": "0"
          },
          "group KD": {
            "hallucination": "3"
          }
        }
      }
    ],
    "blinding_check": null,
    "enrollment": {
      "start": "2017-08",
      "end": "2018-01"
    },
    "registration": {
      "number": "NCT03194594",
      "date": null
    },
    "note": "No depression numbers: PHQ-9 (before surgery and on postoperative days 1 and 3) is reported only in Fig. 2 (caption 'Perioperative change of Patient Health Questionnaire (PHQ)-9 scores'), and the text holds no values printed on it; the Results and abstract give only P values (groups K and KD lower on days 1 and 3 than before surgery and than group D, P < 0.01; group D unchanged; K vs KD not different). The 3.10, 3.50, 2.95 (SD 0.67) in the sample-size paragraph are hypothesized means from a preliminary investigation, not results. Arms: randomized n = 99 per group (Methods and abstract); analysed n is from Table 2's column headers (group K 92, group D 95, group KD 94), also used as each pain entry's n. Results: 297 received study medication after randomization and 16 were withdrawn (conversion to open surgery, lost to follow-up, re-exploration for bleeding, refusal of postoperative assessment); the flow diagram (Fig. 1) has no numbers in the text. Pain: Table 2 heads the VAS rows 'Pain intensity with effort', so these are VAS with effort although the design says rest or movement not stated; VAS at 1 h and 6 h (Table 2) left out as outside 18-30 h. Table 2 marks group KD's VAS 24 h with * (P < 0.01 vs group K) and its PCA consumption with ** (P < 0.05 vs the other two groups). PCA units are not printed (row label 'PCA consumption for 24 after surgery'); the pump held morphine 60 mg, ketorolac 150 mg and ramosetron 0.6 mg in 100 ml of saline (basal 2 ml/h, 0.5 ml boluses, 15-min lockout). Adverse events: hallucination is printed as n (%) in Table 2 (group D 0 (0), group KD 3 (3.2)); its timing is not stated, coded postoperative because the study drugs' side effects were analysed with postoperative nausea and vomiting and the row sits in that block of Table 2. Genital pruritus and nausea or vomiting are also reported; no other psychotomimetic events and no count of any adverse event. No blinding check (only 'double-blinded method'). Enrollment: the Results give no dates; the Methods say 'The study was performed at University Hospital from August 2017 to January 2018.' Registration: NCT03194594 at clinicaltrials.gov, no registration date printed; IRB approval (No. 3031) April 2016."
  }
]