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

Martinez 2007.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 41
Country: France
Setting: secondary care
Dates conducted: not reported
Postoperative opioid used and delivery: morphine PCA
Pain score collection: blinded nurse
Concurrent postoperative analgesics: none reported
Participants Inclusion criteria
  1. Total hip arthroplasty

  2. General anaesthesia


Exclusion criteria
  1. Contraindications to parecoxib (including cardiovascular pathology and renal insufficiency)

  2. Previous hip surgery

  3. Hip trauma

  4. Preoperative use of opioid or NSAID within 48 hours before surgery

  5. Patients were withdrawn from the study if they withdrew consent during the follow‐up period, developed a complication that required intervention within 24 hours after surgery or required prolonged (> 60 minutes) mechanical ventilation after surgery.

Interventions Group Pre (22 participants): 40 mg IV parecoxib at induction, placebo at wound closure and 40 mg IV parecoxib at 12 hours
Group Post (19 participants): placebo at induction, 40 mg IV parecoxib at wound closure and 40 mg IV parecoxib 12 hours after surgery
Outcomes
  1. Postoperative pain at rest and movement (0‐100 mm VAS 4 hourly for 24 hours)

  2. Morphine consumption (mg consumed during 24 hours after surgery)

  3. Time to analgesic request (minutes)

  4. Morphine side effects (incidence of sedation, urinary retention and nausea or vomiting during 24 hours)

  5. Intraoperative bleeding (mL and incidence of transfusion at day 5 after surgery)

Notes Funding: NIH Grant GM 061655 (Bethesda, MD), the Gheens Foundation (Louisville, KY), the
Joseph Drown Foundation (Los Angeles, CA) and the Commonwealth of Kentucky Research Challenge
Trust Fund (Louisville, KY). No financial support of Pfizer
Declarations of interest: not reported
Authors contacted: no
Other: pain score data for 24 hours extracted from graph and SD estimated. Time to analgesic request not time‐to‐event
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated. Quote: "computer‐generated codes"
Allocation concealment (selection bias) Low risk Quote: "the randomization instructions were stored in sequentially numbered opaque envelopes opened the day of surgery before induction of anesthesia".
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo used. Quote: "...all patients received three IV injections: one with anesthesia induction, a second at wound closure, and a third 12 hours after induction".
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinded
Incomplete outcome data (attrition bias)
All outcomes High risk Fourteen exclusions. Quote: "Eleven patients were eliminated from the study: two patients withdrew consent, one required prolonged postoperative mechanical ventilation, two were inadvertently given paracetamol (one of the exclusion criterion), four because of inadequate order of treatment attribution (third injection made instead the second), one had a surgical complication that required intervention, and one because the patient’s data were lost...Two additional patients were eliminated from the study after morphine titration in the PACU".
Selective reporting (reporting bias) Unclear risk No protocol or trial registration
Other bias Low risk Similar baseline characteristics and no drug company involvement