title: Side effects of hyperbaric oxygen therapy in children with cerebral palsy.
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.
  
  
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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).
authors.affiliation: Centre for Clinical Epidemiology and Community Studies, Randomized Clinical Trial Unit, Jewish General Hospital, McGill University, Montreal, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Muller-Bolla
authors.forename: J P
authors.initials: JP
authors.lastname: Collet
authors.forename: T
authors.initials: T
authors.lastname: Ducruet
authors.forename: A
authors.initials: A
authors.lastname: Robinson
mesh_terms: D000704:Analysis of Variance; D001469:Barotrauma / Q000150:complications*; D002547:Cerebral Palsy / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004432:Ear, Middle / Q000293:injuries*; D005260:Female; D006801:Humans; D006931:Hyperbaric Oxygenation / Q000009:adverse effects*; D008297:Male