Intranasal sufentanil/ketamine analgesia in children

Abstract

Summary Background 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. Objectives To investigate a pediatric formulation of intranasal sufentanil 0.5 mcg·kg -1 and ketamine 0.5 mg·kg -1 for procedural pain and to characterize the pharmacokinetic (PK) profile. Methods 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. Results Children had a mean age of 8.8 (sd 4.9) years and weight 35.2 (sd 20.1) kg. Sufentanil/ketamine nasal spray was effective (procedural pain intensity scores ≤5 (0-10)) in 78% of the painful procedures. The spray was well accepted by 94% of the children. Oxygen saturation and heart rate remained stable, and sedation was minimal. The bioavailability of sufentanil and ketamine was 24.6% and 35.8%, respectively. Maximum plasma concentration (C max ) of sufentanil was 0.042 mcg·l -1 (coefficient of variation (CV) 12.9%) at 13.8 min (CV 12.4%) (T max ). C max for ketamine was 0.102 mg·l -1 (CV 10.8%), and T max was 8.5 min (CV 17.3%). Conclusion Sufentanil/ketamine nasal spray provided rapid onset of analgesia for a variety of painful procedures with few adverse effects and has promising features for use in pediatric procedural pain management. © 2013 John Wiley & Sons Ltd.