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Side effects of hyperbaric oxygen therapy in children with cerebral palsy
M Muller-Bolla1, J P Collet, T Ducruet
1Centre for Clinical Epidemiology and Community Studies, Randomized Clinical Trial Unit, Jewish General Hospital, McGill University, Montreal, Canada.
Insights
Hyperbaric oxygen therapy for cerebral palsy in children showed no benefits and increased middle ear barotrauma. This randomized trial found no oxygen toxicity, but ear injuries were more common in the treatment group.
Area of Science:
- Pediatric Medicine
- Neurology
- Hyperbaric Medicine
Background:
- Assessing the efficacy and safety of hyperbaric oxygen (HBO2) therapy for pediatric cerebral palsy.
- Utilizing a double-blind, placebo-controlled, multi-center randomized clinical trial design.
- Intention-to-treat analysis indicated no significant beneficial effect of HBO2 therapy.
Purpose of the Study:
- To evaluate the side effects of hyperbaric oxygen (HBO2) therapy in children with cerebral palsy.
- To compare the safety profile of HBO2 therapy versus a control condition in this pediatric population.
Main Methods:
- 111 children (3-12 years) received 40 one-hour sessions over 8 weeks.
- Treatment group: 100% oxygen at 1.75 atm abs; Control group: air at 1.3 atm abs.
- Health surveillance included physician-led general and ear examinations before and after sessions.
Main Results:
- No events related to oxygen toxicity were observed.
- Middle ear barotrauma occurred significantly more in the HBO2 group (50%) than the control group (27.8%).
- Other recorded clinical events were infrequent and similar between groups.
Conclusions:
- Short-term HBO2 therapy at 1.75 atm abs significantly increased middle ear barotrauma in children.
- The study did not demonstrate a beneficial effect of HBO2 therapy for cerebral palsy in children.
- The primary safety concern identified was an increased risk of ear-related injuries.
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).
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