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.
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Notes
As computer training condition, in itself or in combination with nasal spray condition, was not significantly associated with total frequency of reported side-effects or incidence of specific side-effects at any time point, we collapsed data from both computer training conditions to assess side-effects of nasal spray condition.
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Funding
This work was supported by grants G.0774.15 and G.0757.18 from Research Foundation Flanders (FWO) and CREA/12/004 from Research Fund KU Leuven. MJBK was supported by an Advanced Grant from the European Research Council.
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Verhees, M.W.F.T., Houben, J., Ceulemans, E. et al. No side-effects of single intranasal oxytocin administration in middle childhood. Psychopharmacology 235, 2471–2477 (2018). https://doi.org/10.1007/s00213-018-4945-1
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DOI: https://doi.org/10.1007/s00213-018-4945-1