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. 2021 Jun 14;2021(6):CD012978. doi: 10.1002/14651858.CD012978.pub2

Boccara 2005.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 48
Country: France
Setting: secondary care
Dates conducted: not reported
Postoperative opioid used and delivery: nalbuphine
Pain score collection: not reported
Concurrent postoperative analgesics: paracetamol
Participants Inclusion criteria
  1. Aged 18–70 years old

  2. ASA 1 or 2

  3. Laparoscopic cholecystectomy


Exclusion criteria
  1. Allergy to paracetamol, NSAIDs or opioids

  2. Severe hepatic, renal, gastric or bleeding disorders

  3. Received analgesic drugs within two weeks before surgery

Interventions Group K1 (24 participants): IV ketoprofen 100 mg before induction and IV saline end of surgery and continued for 24 hours
Group K2 (24 participants): IV saline before induction and IV ketoprofen 100 mg end of surgery and continued for 24 hours
Outcomes
  1. Postoperative pain (0‐100 mm VAS hourly for 24 hours)

  2. Nalbuphine consumption (mg consumed at 8 and 24 hours)

  3. Time to analgesic request (minutes if pain > 30 mm or > 50 mm)

  4. Sedation (during postoperative period, yes/no if sedation score > 2)

  5. Nausea and vomiting (yes/no during postoperative period)

  6. Adverse events (gastralgia, bleeding and anaphylaxis, yes/no during the postoperative period)

  7. Patient satisfaction (0‐5 scale, reported as number of patients with score 4 or 5)

Notes Funding: none reported
Declarations of interest: not reported
Authors contacted: yes
Other: pain score converted to 0‐10 scale, pain score data extracted from graph and taken from one hour to allow postoperative dosing to take effect. Authors contacted for raw patient satisfaction data
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated. Quote: "computer‐generated random list"
Allocation concealment (selection bias) Unclear risk No mention
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo used. Quote: "in group K1, ketoprofen was administered before induction and saline after surgery".
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinded. Quote: "none of the patients, managing anaesthetists or nurses were aware of the randomization code".
Incomplete outcome data (attrition bias)
All outcomes Low risk Exclusions unlikely to bias as equal in number. Quote: "Six patients were excluded from postoperative data analysis because four needed intraoperative laparotomy (one in K1, one in K2 and two in P1) and two for incomplete data (one in K1 and one in K2)".
Selective reporting (reporting bias) Unclear risk No protocol or trial registration
Other bias High risk More females in K2 group (Gerbershagen 2014)