Randomized clinical trial comparing oral prednisone (50 mg) with placebo before laparoscopic cholecystectomy
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Intravenous administration of dexamethasone 90 min before laparoscopic cholecystectomy improves surgical outcome but may be impractical. The objective of this study was to assess the clinical efficacy of oral self-administration of prednisone 2 h before ambulatory laparoscopic cholecystectomy.
In a double-blind placebo-controlled study, 200 patients were randomized to oral administration of prednisone (50 mg) or placebo 2 h before laparoscopic cholecystectomy. Patients received a similar standardized anaesthetic, surgical, and analgesic treatment. The primary outcome was pain 24 h after surgery and secondary outcomes were fatigue and malaise 24 h after surgery. Outcome parameters were registered before operation, on the day of operation, and the following two days. Analgesic and antiemetic requirements were registered, and nausea and vomiting were assessed twice within the first 24 h. Side-effects and 30-day follow-up for morbidity were registered.
Data from 184 patients were available for statistical analysis. There were no significant differences in side-effects or complications between the surgical groups (P > 0.05). No significant intergroup differences in 24-h pain, fatigue or malaise scores or any other variables were found (P > 0.05).
There is no important clinical gain of preoperative oral steroid administration compared with placebo in patients undergoing laparoscopic cholecystectomy.
KeywordsCholecystectomy Prednisone Corticosteroids Pain Fatigue Nausea and vomiting Outcome
The authors would like to thank Nycomed Danmark A/S, Denmark for providing randomized concealed containers of the study drugs for the trial. Research nurses Dorthe Greve Jørgensen, Jeanette Juncker Madsen, and Irene Tarp Jørgensen are thanked for invaluable help and enthusiasm during the study.
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