Martine W F T Verhees1, Janne Houben2, Eva Ceulemans3, Marian J Bakermans-Kranenburg4, Marinus H van IJzendoorn5,6, Guy Bosmans2. 1. Parenting and Special Education Research Unit, KU Leuven, Leopold Vanderkelenstraat 32, 3000, Leuven, Belgium. martine.verhees@kuleuven.be. 2. Parenting and Special Education Research Unit, KU Leuven, Leopold Vanderkelenstraat 32, 3000, Leuven, Belgium. 3. Quantitative Psychology and Individual Differences Research Unit, KU Leuven, Tiensestraat 102, 3000, Leuven, Belgium. 4. Centre for Child and Family Studies, Leiden University, Wassenaarseweg 52, 2333 AK, Leiden, The Netherlands. 5. Department of Psychology, Education and Child Studies, Erasmus University Rotterdam, Burgemeester Oudlaan 50, 3062 PA, Rotterdam, The Netherlands. 6. Primary Care Unit, School of Clinical Medicine, University of Cambridge, Cambridge, UK.
Abstract
BACKGROUND: Despite growing interest in the (therapeutic) use of intranasal oxytocin administration in children, the potential side-effects of intranasal oxytocin have remained largely unclear to date. The current study is the first double-blind randomized controlled trial to examine side-effects following single administration of oxytocin nasal spray in elementary school-aged children. METHODS:One hundred children (8-12 years old) were randomly assigned to receive oxytocin or placebo nasal spray. We assessed side-effects by means of a standardized, drug-specific questionnaire and an open-ended question at two time points: 90 min after nasal spray administration and 24 h after administration. RESULTS: There were no significant associations between nasal spray condition and total frequency of reported side-effects or reports of specific side-effects. Children and their mothers were unable to correctly guess nasal spray allocation, further supporting that the subjective experience of oxytocin versus placebo nasal spray effects was similar. Moreover, the majority of reported side-effects were classified as mild and ceased within 24 h after the procedure, indicating that the nasal sprays were well tolerated. CONCLUSION: In all, this study is the first randomized controlled trial to provide information on the safety of intranasal oxytocin administration in middle childhood. The current study suggests that single administration of intranasal oxytocin is likely safe in elementary school-aged children.
RCT Entities:
BACKGROUND: Despite growing interest in the (therapeutic) use of intranasal oxytocin administration in children, the potential side-effects of intranasal oxytocin have remained largely unclear to date. The current study is the first double-blind randomized controlled trial to examine side-effects following single administration of oxytocin nasal spray in elementary school-aged children. METHODS: One hundred children (8-12 years old) were randomly assigned to receive oxytocin or placebo nasal spray. We assessed side-effects by means of a standardized, drug-specific questionnaire and an open-ended question at two time points: 90 min after nasal spray administration and 24 h after administration. RESULTS: There were no significant associations between nasal spray condition and total frequency of reported side-effects or reports of specific side-effects. Children and their mothers were unable to correctly guess nasal spray allocation, further supporting that the subjective experience of oxytocin versus placebo nasal spray effects was similar. Moreover, the majority of reported side-effects were classified as mild and ceased within 24 h after the procedure, indicating that the nasal sprays were well tolerated. CONCLUSION: In all, this study is the first randomized controlled trial to provide information on the safety of intranasal oxytocin administration in middle childhood. The current study suggests that single administration of intranasal oxytocin is likely safe in elementary school-aged children.
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