Intranasal sufentanil/ketamine analgesia in children

TY - JOUR

T1 - Intranasal sufentanil/ketamine analgesia in children

AU - Nielsen, Bettina Nygaard

AU - Friis, Susanne M

AU - Rømsing, Janne

AU - Schmiegelow, Kjeld

AU - Anderson, Brian J

AU - Ferreiros, Nerea

AU - Labocha, Sandra

AU - Henneberg, Steen W

PY - 2014/2

Y1 - 2014/2

N2 - 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 (Cmax) of sufentanil was 0.042 mcg·l-1 (coefficient of variation (CV) 12.9%) at 13.8 min (CV 12.4%) (Tmax). Cmax for ketamine was 0.102 mg·l-1 (CV 10.8%), and Tmax 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.

AB - 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 (Cmax) of sufentanil was 0.042 mcg·l-1 (coefficient of variation (CV) 12.9%) at 13.8 min (CV 12.4%) (Tmax). Cmax for ketamine was 0.102 mg·l-1 (CV 10.8%), and Tmax 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.

U2 - 10.1111/pan.12268

DO - 10.1111/pan.12268

M3 - Journal article

SN - 1155-5645

VL - 24

SP - 170

EP - 180

JO - Paediatric Anaesthesia

JF - Paediatric Anaesthesia

IS - 2

ER -