[
  {
    "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",
        "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",
        "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",
        "values": {
          "group D": {
            "mean": "65.3",
            "sd": "5.2",
            "n": "95"
          },
          "group KD": {
            "mean": "61.1",
            "sd": "7.2",
            "n": "94"
          }
        }
      }
    ],
    "adverse_events": [
      {
        "window": "overall",
        "location": "Table 2",
        "values": {
          "group D": {
            "hallucination": "0"
          },
          "group KD": {
            "hallucination": "3"
          }
        }
      }
    ],
    "blinding_check": null,
    "enrollment": {
      "start": "2017-08",
      "end": "2018-01"
    },
    "registration": {
      "registry": "clinicaltrials.gov",
      "number": "NCT03194594",
      "date": null
    },
    "note": "Depression: PHQ-9 was measured before surgery and on postoperative days 1 and 3, but its values appear only in Fig. 2, and the text holds only the figure's caption, no printed values; the Results give only P < 0.01 for groups K and KD versus pre-operation and versus group D, and no pre/post difference in group D. So no depression entry is recorded. The 3.10, 3.50 and 2.95 (SD 0.67) in Methods are sample-size assumptions from a preliminary investigation, not results. Arms: group K (ketamine alone, design role other) is left out. Analysed and every value's n are Table 2's column headers (group D n = 95, group KD n = 94); 16 of the 297 randomized were withdrawn (conversion to open surgery, loss to follow-up, re-exploration, refusal; Fig. 1, whose per-arm counts are not in the text). Pain: Table 2 heads the VAS rows 'Pain intensity with effort', so these are scores with effort, although the design's measure name says rest or movement not stated. VAS at 1 h and 6 h (day 0) are left out under the codebook's 24/48 h rule. Table 2 prints no unit for 'PCA consumption for 24 after surgery'; the PCA held morphine 60 mg, ketorolac 150 mg and ramosetron 0.6 mg in 100 ml saline (basal 2 ml/h, 0.5-ml boluses). Table 2 marks group KD's VAS at 1, 6 and 24 h with * (P < 0.01 vs group K) and its PCA value with ** (P < 0.05 vs the other two groups); the markers are dropped from the values. Adverse events: Table 2's hallucination row states no time window, so it is coded overall. Table 2 also gives PONV at 1, 6, 24 and 48 h and genital pruritus, outside the codebook's categories. Enrollment is from Methods ('performed at University Hospital from August 2017 to January 2018'); the Results give no dates. No registration date is given. No blinding check is reported. The batch text holds the Methods and Results twice (an excerpt and the full PDF text), and the copies agree."
  }
]
