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

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

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.

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)