M Muller-Bolla1, J P Collet, T Ducruet, A Robinson. 1. Centre for Clinical Epidemiology and Community Studies, Randomized Clinical Trial Unit, Jewish General Hospital, McGill University, Montreal, Canada.
Abstract
BACKGROUND: This article reports the side effects observed in a double-blind placebo-controlled multi-center randomized clinical trial carried out to assess the efficacy and safety of hyperbaric oxygen (HBO2) therapy in children with cerebral palsy. Intention-to-treat analysis did not prove to have a beneficial effect. MATERIAL AND METHODS: 111 children aged 3 to 12 years were included and followed for 8 weeks. They all received 40 compressions of 1 hour (5 days per week). In the treated group (n=57), HBO2 sessions consisted of an exposure to 100% oxygen at 1.75 atmosphere absolute (atm abs) while children in the control group (n=54) received air at 1.3 atm abs. A physician carried out a general health surveillance including an ear examination prior to and immediately following each session. All clinical events occurring during the course of the study were recorded. FINDINGS: Events were classified in 3 categories: Events related to pressure/volume changes, events related to oxygen toxicity, and other events. No events due to oxygen toxicity were noted. Only middle ear barotrauma significantly differed according to the groups (50% in HBO2 session group versus 27.8% in control group). Other events were rare and equivalent in both groups. CONCLUSION: Short-term exposure to HBO2 at medium level pressure (1.75 atm abs) was responsible for a significant increase of middle ear barotrauma compared to children that received very low external pressure (1.3 atm abs).
RCT Entities:
BACKGROUND: This article reports the side effects observed in a double-blind placebo-controlled multi-center randomized clinical trial carried out to assess the efficacy and safety of hyperbaric oxygen (HBO2) therapy in children with cerebral palsy. Intention-to-treat analysis did not prove to have a beneficial effect. MATERIAL AND METHODS: 111 children aged 3 to 12 years were included and followed for 8 weeks. They all received 40 compressions of 1 hour (5 days per week). In the treated group (n=57), HBO2 sessions consisted of an exposure to 100% oxygen at 1.75 atmosphere absolute (atm abs) while children in the control group (n=54) received air at 1.3 atm abs. A physician carried out a general health surveillance including an ear examination prior to and immediately following each session. All clinical events occurring during the course of the study were recorded. FINDINGS: Events were classified in 3 categories: Events related to pressure/volume changes, events related to oxygentoxicity, and other events. No events due to oxygentoxicity were noted. Only middle ear barotrauma significantly differed according to the groups (50% in HBO2 session group versus 27.8% in control group). Other events were rare and equivalent in both groups. CONCLUSION: Short-term exposure to HBO2 at medium level pressure (1.75 atm abs) was responsible for a significant increase of middle ear barotrauma compared to children that received very low external pressure (1.3 atm abs).