Conditions: Pain
Keywords: Painful medical procedures
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Intranasal combination of sufentanil and ketamine. Dose of sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.

Interventions: intervention 1: Intranasal sufentanil/ketamine
Intervention descriptions: intervention 1: Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose

Protocol document: