PURPOSE:Corrective strabismus surgery is associated with moderate pain after surgery. Postoperative analgesia for these patients may include topical local anesthetic agents and topical non-steroidal anti-inflammatory drugs. In this prospective randomized, double-blind placebo controlled clinical trial we compared the effect of placebo to intraoperative 0.5% topical amethocaine or 0.5% topical ketorolac on pain control after strabismus surgery in children. METHODS: Following Institutional Ethics Committee approval and parental consent, we prospectively studied 51 healthy children between the ages of two and seven years who were undergoingelective bilateral recession surgery in a randomized, double-blind controlled clinical trial. Children were randomized to receive either placebo (normal saline), 0.5% amethocaine or 0.5% ketorolac eye drops at the start and end of strabismus repair surgery. Pain was assessed with a modified Children's Hospital of Eastern Ontario Pain Score in the recovery room. If the pain score was greater than 6, the patient was administered a single oral dose of acetaminophen (20 mg x kg(-1)). RESULTS: The groups had similar demographic data. Duration of surgery and anesthesia, time spent in recovery room and length of hospital stay between the three groups were similar. Pain scores and analgesic requirements while in the hospital were also similar between the groups as was the time to first analgesic administration. There were no side effects observed in any of the three treatment arms. CONCLUSION: We conclude that there is no improvement in postoperative pain control after the intraoperative administration of topical 0.5% ketorolac or 0.5% amethocaine when compared to placebo in children undergoing strabismus surgery.
RCT Entities:
PURPOSE: Corrective strabismus surgery is associated with moderate pain after surgery. Postoperative analgesia for these patients may include topical local anesthetic agents and topical non-steroidal anti-inflammatory drugs. In this prospective randomized, double-blind placebo controlled clinical trial we compared the effect of placebo to intraoperative 0.5% topical amethocaine or 0.5% topical ketorolac on pain control after strabismus surgery in children. METHODS: Following Institutional Ethics Committee approval and parental consent, we prospectively studied 51 healthy children between the ages of two and seven years who were undergoing elective bilateral recession surgery in a randomized, double-blind controlled clinical trial. Children were randomized to receive either placebo (normal saline), 0.5% amethocaine or 0.5% ketorolac eye drops at the start and end of strabismus repair surgery. Pain was assessed with a modified Children's Hospital of Eastern Ontario Pain Score in the recovery room. If the pain score was greater than 6, the patient was administered a single oral dose of acetaminophen (20 mg x kg(-1)). RESULTS: The groups had similar demographic data. Duration of surgery and anesthesia, time spent in recovery room and length of hospital stay between the three groups were similar. Pain scores and analgesic requirements while in the hospital were also similar between the groups as was the time to first analgesic administration. There were no side effects observed in any of the three treatment arms. CONCLUSION: We conclude that there is no improvement in postoperative pain control after the intraoperative administration of topical 0.5% ketorolac or 0.5% amethocaine when compared to placebo in children undergoing strabismus surgery.