No Side-effects of Single Intranasal Oxytocin Administration in Middle Childhood

Overview

Journal Psychopharmacology (Berl)

Specialty Pharmacology

Date 2018 Jun 20

PMID 29915962

Citations 11

Authors

Martine W F T Verhees

Janne Houben

Eva Ceulemans

Marian J Bakermans-Kranenburg

Marinus H van IJzendoorn

Guy Bosmans

Affiliations

Soon will be listed here.

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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References

DeMayo M, Song Y, Hickie I, Guastella A . 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. Paediatr Drugs. 2017; 19(5):391-410. DOI: 10.1007/s40272-017-0248-y. View

Rief W, Avorn J, Barsky A . Medication-attributed adverse effects in placebo groups: implications for assessment of adverse effects. Arch Intern Med. 2006; 166(2):155-60. DOI: 10.1001/archinte.166.2.155. View

Van IJzendoorn M, Bakermans-Kranenburg M . The Role of Oxytocin in Parenting and as Augmentative Pharmacotherapy: Critical Issues and Bold Conjectures. J Neuroendocrinol. 2015; 28(8). DOI: 10.1111/jne.12355. View

MacDonald E, Dadds M, Brennan J, Williams K, Levy F, Cauchi A . A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research. Psychoneuroendocrinology. 2011; 36(8):1114-26. DOI: 10.1016/j.psyneuen.2011.02.015. View

Yatawara C, Einfeld S, Hickie I, Davenport T, Guastella A . The effect of oxytocin nasal spray on social interaction deficits observed in young children with autism: a randomized clinical crossover trial. Mol Psychiatry. 2015; 21(9):1225-31. PMC: 4995545. DOI: 10.1038/mp.2015.162. View

Greenhill L, Vitiello B, Riddle M, Fisher P, Shockey E, March J . Review of safety assessment methods used in pediatric psychopharmacology. J Am Acad Child Adolesc Psychiatry. 2003; 42(6):627-33. DOI: 10.1097/01.CHI.0000046841.56865.37. View

Dadds M, MacDonald E, Cauchi A, Williams K, Levy F, Brennan J . Nasal oxytocin for social deficits in childhood autism: a randomized controlled trial. J Autism Dev Disord. 2013; 44(3):521-31. DOI: 10.1007/s10803-013-1899-3. View

Einfeld S, Smith E, McGregor I, Steinbeck K, Taffe J, Rice L . A double-blind randomized controlled trial of oxytocin nasal spray in Prader Willi syndrome. Am J Med Genet A. 2014; 164A(9):2232-9. DOI: 10.1002/ajmg.a.36653. View

Miller G . Neuroscience. The promise and perils of oxytocin. Science. 2013; 339(6117):267-9. DOI: 10.1126/science.339.6117.267. View

10.

Doig G, Simpson F . Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005; 20(2):187-91. DOI: 10.1016/j.jcrc.2005.04.005. View

11.

Loke Y, Price D, Herxheimer A . Systematic reviews of adverse effects: framework for a structured approach. BMC Med Res Methodol. 2007; 7:32. PMC: 1933432. DOI: 10.1186/1471-2288-7-32. View

12.

Verhees M, Ceulemans E, Bakermans-Kranenburg M, van IJzendoorn M, De Winter S, Bosmans G . The effects of Cognitive Bias Modification training and oxytocin administration on trust in maternal support: study protocol for a randomized controlled trial. Trials. 2017; 18(1):326. PMC: 5513044. DOI: 10.1186/s13063-017-2077-2. View

13.

Guastella A, Hickie I, McGuinness M, Otis M, Woods E, Disinger H . Recommendations for the standardisation of oxytocin nasal administration and guidelines for its reporting in human research. Psychoneuroendocrinology. 2012; 38(5):612-25. DOI: 10.1016/j.psyneuen.2012.11.019. View