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
Exclusion criteria
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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 |
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Outcomes |
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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 |
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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 |