No side-effects of single intranasal oxytocin administration in middle childhood
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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.
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.
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.
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.
KeywordsOxytocin Side-effects Middle childhood Randomized controlled trial Intranasal administration
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.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
- DeMayo MM, Song YJC, Hickie IB, Guastella AJ (2017) A review of the safety, efficacy and mechanisms of delivery of nasal oxytocin in children: therapeutic potential for autism and Prader-Willi syndrome, and recommendations for future research. Pediatr Drugs 19:391–410. https://doi.org/10.1007/s40272-017-0248-y CrossRefGoogle Scholar
- Einfeld SL, Smith E, McGregor IS, Steinbeck K, Taffe J, Rice LJ, Horstead SK, Rogers N, Hodge MA, Guastella AJ (2014) A double-blind randomized controlled trial of oxytocin nasal spray in Prader Willi syndrome. Am J Med Genet A 164:2232–2239. https://doi.org/10.1002/ajmg.a.36653 CrossRefGoogle Scholar
- Greenhill LL, Vitiello B, Riddle MA et al (2003) Review of safety assessment methods used in pediatric psychopharmacology. J Am Acad Child Psy 42:627–633. https://doi.org/10.1097/01.CHI.0000046841.56865.37 CrossRefGoogle Scholar
- Grossmann K, Grossmann KE, Kindler H, Zimmermann P (2008) A wider view of attachment and exploration: the influence of mothers and fathers on the development of psychological security from infancy to young adulthood. In: Cassidy J, Shaver PR (eds) Handbook of attachment: theory, research, and clinical applications, 2nd edn. The Guilford Press, New York, pp 857–879Google Scholar
- Guastella AJ, Hickie IB, McGuinness MM, Otis M, Woods EA, Disinger HM, Chan H, Chen TF, Banati RB (2013) Recommendations for the standardisation of oxytocin nasal administration and guidelines for its reporting in human research. Psychoneuroendocrino 38:612–625. https://doi.org/10.1016/j.psyneuen.2012.11.019 CrossRefGoogle Scholar
- Van IJzendoorn MH, Bakermans-Kranenburg MJ (2016) The role of oxytocin in parenting and as augmentative pharmacotherapy: critical issues and bold conjectures. J Neuroendocrinol 28. https://doi.org/10.1111/jne.12355
- Verhees MWFT, Ceulemans E, Bakermans-Kranenburg MJ, Van IJzendoorn MH, De Winter S, Bosmans G (2017) The effects of cognitive bias modification training and oxytocin administration on trust in maternal support: study protocol for a randomized controlled trial. Trials 18:326. https://doi.org/10.1186/s13063-017-2077-2 CrossRefPubMedPubMedCentralGoogle Scholar
- Yatawara CJ, Einfeld SL, Hickie IB, Davenport TA, Guastella AJ (2016) The effect of oxytocin nasal spray on social interaction deficits observed in young children with autism: a randomized clinical crossover trial. Mol Psychiatry 21:1225–1231. https://doi.org/10.1038/mp.2015.162 CrossRefPubMedGoogle Scholar