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Published on: April 8, 2013
No side-effects of single intranasal oxytocin administration in middle childhood
Martine W F T Verhees1, Janne Houben2, Eva Ceulemans3
1Parenting and Special Education Research Unit, KU Leuven, Leopold Vanderkelenstraat 32, 3000, Leuven, Belgium. martine.verhees@kuleuven.be.
Insights
Single intranasal oxytocin administration appears safe for elementary school children. This randomized controlled trial found no significant side-effects, with most reported symptoms being mild and temporary.
Area of Science:
- Pediatric Psychology
- Neuroendocrinology
- Clinical Trials
Background:
- Limited data exists on intranasal oxytocin side-effects in children.
- Growing interest in therapeutic uses of intranasal oxytocin for pediatric conditions.
Purpose of the Study:
- To investigate the safety and side-effects of single-dose intranasal oxytocin in elementary school-aged children.
- To conduct the first double-blind randomized controlled trial on this topic.
Main Methods:
- 100 children (8-12 years) received either oxytocin or placebo nasal spray.
- Side-effects assessed via standardized questionnaire and open-ended questions at 90 minutes and 24 hours post-administration.
Main Results:
- No significant differences in reported side-effects between oxytocin and placebo groups.
- Participants and parents could not distinguish between oxytocin and placebo.
- Most reported side-effects were mild and resolved within 24 hours.
Conclusions:
- Single intranasal oxytocin administration is likely safe in elementary school-aged children.
- This study provides crucial safety data for intranasal oxytocin use in middle childhood.
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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