3-33 Intranasal sufentanil and s-ketamine combination for treatment of procedural pain in children - Pharmacovigilance data from routine clinical care

Intranasal sufentanil and s-ketamine combination for treatment of procedural pain in children - Pharmacovigilance data from routine clinical care

Bettina Nygaard Nielsen1, Stefan Lundeberg2, Steen W. Henneberg1

1) Denmark 2) Sweden

Treatment of procedural pain in children remains a clinical challenge to health care professionals and new treatment options are warranted. The aim of this study was to investigate the safety and effect of intranasal sufentanil and s-ketamine in a free dosage combination used for treatment of procedural pain in routine clinical care at Astrid Lindgren Children’s Hospital.

The study included retrospective data from patient records for children aged 1-18 years receiving a free combination of sufentanil and s-ketamine for treatment of procedural pain in an ambulatory setting. Data were collected for the period 2004-2015 and preliminary data from 5 years are presented.

In total, 285 medical procedures with the combination of intranasal sufentanil and s-ketamine were performed during a five year period. The children’s median age was 5.0 years (range 1.0-17.5). The median doses of sufentanil and s-ketamine were 0.5 microg/kg (range 0.2-1.3) and 0.5 mg/kg (range 0.2-5.0), respectively. In 54% of the procedures nitrous oxide up to 50 % were added. The medical procedures were botox injections 165 (58%), burn dressing changes 109 (38%), others 10 (4%). 278 (98%) of the procedures were successfully performed and analgesic effect was reported as sufficient for 258 (91%). In 45 of the procedures (16%) one or more adverse event was reported. Adverse events included episodes of nausea and/or vomiting 34 (12%), dizziness 5 (1.8%), agitation/paradoxical reaction 3 (1%), nasal irritation 3 (1%), visual disturbance/abnormal dreams 2 (0.7%). Nitrous oxide could partly explain the incidence of nausea/vomiting. No respiratory depression or serious adverse events were reported.

In conclusion no safety concerns were raised from this preliminary analysis. Intranasal sufentanil and s-ketamine combination may be safely administered for treatment of procedural pain in an ambulatory setting.

Acknowledgments/Disclosures: Financial support was received from a grant from the Novo Nordisk Foundation.