NCT01047241

Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Danish University of Pharmaceutical Sciences · Academic / Other
• Sex: All
• Age: 1 Year – 19 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to investigate the absorption and clinical effect of nasal administration of an analgesic nasal spray containing sufentanil+ketamine for pain related to medical procedures in hospitalized children.

Detailed description

The management of procedural pain in children ranges from physical restraint to pharmacological interventions. Pediatric formulations that permit accurate dosing, are accepted by children and a have a rapid onset of analgesia are lacking. The objectives were to investigate a pediatric formulation of intranasal sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg for procedural pain and to characterize the pharmacokinetic (PK) profile. Fifty children (≥10 kg) scheduled for a painful procedure were included in this prospective nonrandomized open-label clinical trial. Thirteen of these children had central venous access for drug assay sampling; enabling a compartmental PK analysis using nonlinear mixed-effects models. Pain intensity before and during the procedure was measured using age-appropriate pain scales. Heart rate, oxygen saturation and sedation were recorded.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Intranasal sufentanil/ketamine	Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2010-01-12
• Last updated: 2014-09-17
• Results posted: 2014-09-17

Locations

1 site across 1 country: Denmark