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

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.

Inclusion criteria

• Children and adolescents treated at the University Hospital, Rigshospital
• Painful medical procedure related to the patients treatment
• Patient and/or the parents must be able to understand and speak danish
• Negative pregnancy test for girls, when relevant
• Signed informed consent
• Only a light meals or no meals have been ingested 2 hours prior to inclusion

Exclusion criteria

• Allergy to sufentanil or ketamine
• Abnormal nasal cavity
• Have been treated with sufentanil and/or ketamine during the last 48 hours
• Nasal obstruction (rhinitis)