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

Sun 2008.

Study characteristics
Methods Study design: parallel‐group randomized controlled trial
Sample size: 76
Country: USA
Setting: secondary care hospital
Dates conducted: not reported
Postoperative opioid used and delivery: IV fentanyl or oral hydrocodone and acetaminophen in PACU and IV morphine PCA if admitted or oral hydrocodone and acetaminophen if discharged
Pain score collection: blinded researcher
Concurrent postoperative analgesics: none reported postoperatively in addition to above
Participants Inclusion criteria
  1. Age 18‐75 years old

  2. ASA 1‐3

  3. Major plastic surgery procedures (breast augmentation or abdominoplasty with or without liposuction involving the abdomen, buttocks and lower extremities)


Exclusion criteria
  1. Allergy or contraindication to NSAIDs

  2. Chronic NSAID therapy

  3. Received any analgesic medication within a 12‐hour period before the operation

  4. Pregnant or breastfeeding

  5. Alcohol or drug abuse

  6. Bleeding disorder

  7. Unstable neurological, cardiovascular, renal, hepatic or gastrointestinal diseases

  8. Unwilling to complete the follow‐up evaluations

Interventions Group Perioperative (39 participants): 2 celecoxib 200 mg capsules 30–90 minutes before
surgery and 2 placebo capsules 1 hour after surgery and celecoxib 200 mg twice daily postoperatively
Group Postoperative (37 participants): 2 celecoxib 200 mg capsules 1 hour after surgery and 2 placebo capsules 30–90 minutes before surgery and celecoxib 200 mg twice daily postoperatively
Outcomes
  1. Postoperative pain (0‐10 VRS at 0.5, 1, 2, 3, 4, 24, 48 and 72 hours)

  2. Opioid consumption (mg morphine in PACU and at 24, 48 and 72 hours)

  3. Patient satisfaction (unclear scale and time point)

  4. Return of bowel function (in days)

  5. Time to analgesia (minutes)

  6. PACU stay (minutes)

  7. Nausea and vomiting (in PACU, yes/no and requirement for anti‐emetic)

  8. Resume normal diet (days)

  9. Resume normal activity (days)

  10. Quality of recovery (0‐18 VRS at 24, 48 and 72 hours)

  11. Cardiovascular and wound complications (yes/no at 7 and 30 days)

Notes Funding: non‐industry
Declarations of interest: not reported
Authors contacted: no
Other: myocardial infarction not included as no events. Patient satisfaction not included as unclear scale used. Pain score data extracted from graph and 2 hours used for early pain as postoperative intervention given at one hour. Morphine consumption calculated as PACU plus 24 hours and extracted from graph with SD estimated. No outcomes reported as time‐to‐event. Time to bowel movement mean from median and IQR/1.35 to estimate SD
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated. Quote: "...computer generated random number schedule"
Allocation concealment (selection bias) Low risk Pharmacy‐controlled. Quote: "The study medication was prepared by a hospital pharmacist in identical‐appearing capsules according to a computer generated random number schedule".
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐dummy placebo. Quote: "The patients, nurses, surgeons, and anesthesiologists directly involved in the patients’ care were blinded as to the content of the oral study medication capsules".
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinded. Quote: "A trained interviewer who was also blinded to the study medication contacted each patient at 24, 48, and 72 postoperatively to inquire about their maximum VRS pain score".
Incomplete outcome data (attrition bias)
All outcomes Low risk Four participants excluded. Reasons unlikely to cause bias
Selective reporting (reporting bias) Unclear risk No protocol
Other bias Low risk Similar baseline characteristics. Non‐industry funding