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).
%0 Journal Article
%1 Muller-Bolla2006
%A Muller-Bolla, M.
%A Collet, J. P.
%A Ducruet, T.
%A Robinson, A.
%D 2006
%J Undersea Hyperb Med
%K Analysis of Variance; Barotrauma; Cerebral Palsy; Child; Child, Preschool; Double-Blind Method; Ear, Middle; Female; Humans; Hyperbaric Oxygenation; Male
%N 4
%P 237--244
%T Side effects of hyperbaric oxygen therapy in children with cerebral palsy.
%V 33
%X 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).
@article{Muller-Bolla2006,
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).},
added-at = {2014-07-19T20:49:18.000+0200},
author = {Muller-Bolla, M. and Collet, J. P. and Ducruet, T. and Robinson, A.},
biburl = {https://www.bibsonomy.org/bibtex/2714c624711f21cbf727e8c361b7b49f5/ar0berts},
groups = {public},
interhash = {0eef5b9acd973b1d6908ea71f236284f},
intrahash = {714c624711f21cbf727e8c361b7b49f5},
journal = {Undersea Hyperb Med},
keywords = {Analysis of Variance; Barotrauma; Cerebral Palsy; Child; Child, Preschool; Double-Blind Method; Ear, Middle; Female; Humans; Hyperbaric Oxygenation; Male},
number = 4,
pages = {237--244},
pmid = {17004410},
timestamp = {2014-07-19T20:49:18.000+0200},
title = {Side effects of hyperbaric oxygen therapy in children with cerebral palsy.},
username = {ar0berts},
volume = 33,
year = 2006
}