M I Echavez1, D S Mangat. 1. Department of Otolaryngology-Head and Neck Surgery, University of Cincinnati, Ohio.
Abstract
OBJECTIVE: To examine the effects of oral postoperative steroid therapy in facial plastic surgery on mood, edema, and ecchymosis. DESIGN: Double-blind randomized trial with placebo control. SETTING: Private practice, ambulatory care facility. PATIENTS: Any patient who was to undergo a procedure in which we had previously been employing postoperative steroid therapy was a potential participant. Any patient with known contraindications to steroid use was excluded. A consecutive, volunteer sample of 60 of 65 patients approached agreed to participate. Five patients of the 60 who participated were excluded from the final results owing to either study or participant errors, leaving a total sample of 55 patients. All 55 patients completed the study in the 7-day follow-up period. No patients were withdrawn owing to adverse effects. INTERVENTION: Taper of prednisone therapy from 60 mg orally and decreasing by 10 mg each day over a total of 6 days. MAIN OUTCOME MEASURES: Mood, edema, and ecchymosis. RESULTS: No significant differences were noted in mood, edema, or ecchymosis between the placebo and intervention groups. The study observer was blinded to patient groupings in the subjective measures of edema and ecchymosis. The patients rated any changes in mood and were also blinded to the group in which they belonged. CONCLUSIONS: The use of oral steroids given postoperatively in facial plastic surgery may be unnecessary and may subject the patient to undue risk. Further studies would be helpful to determine the potential benefit of steroids given in different dosages, routes, and timing in relation to the procedure.
RCT Entities:
OBJECTIVE: To examine the effects of oral postoperative steroid therapy in facial plastic surgery on mood, edema, and ecchymosis. DESIGN: Double-blind randomized trial with placebo control. SETTING: Private practice, ambulatory care facility. PATIENTS: Any patient who was to undergo a procedure in which we had previously been employing postoperative steroid therapy was a potential participant. Any patient with known contraindications to steroid use was excluded. A consecutive, volunteer sample of 60 of 65 patients approached agreed to participate. Five patients of the 60 who participated were excluded from the final results owing to either study or participant errors, leaving a total sample of 55 patients. All 55 patients completed the study in the 7-day follow-up period. No patients were withdrawn owing to adverse effects. INTERVENTION: Taper of prednisone therapy from 60 mg orally and decreasing by 10 mg each day over a total of 6 days. MAIN OUTCOME MEASURES: Mood, edema, and ecchymosis. RESULTS: No significant differences were noted in mood, edema, or ecchymosis between the placebo and intervention groups. The study observer was blinded to patient groupings in the subjective measures of edema and ecchymosis. The patients rated any changes in mood and were also blinded to the group in which they belonged. CONCLUSIONS: The use of oral steroids given postoperatively in facial plastic surgery may be unnecessary and may subject the patient to undue risk. Further studies would be helpful to determine the potential benefit of steroids given in different dosages, routes, and timing in relation to the procedure.
Authors: Monther Ali Alajmi; Khalid A Al-Abdulhadi; Hamoud Saud Al-Noumas; Gopalan Kavitha Journal: Indian J Otolaryngol Head Neck Surg Date: 2010-01-09