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Intranasal sufentanil/ketamine analgesia in children
Bettina N Nielsen1, Susanne M Friis, Janne Rømsing
1Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Paediatric Pain Service, Department of Anaesthesiology, The Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Insights
This study shows that intranasal sufentanil and ketamine nasal spray is an effective and well-tolerated option for managing procedural pain in children. The formulation offers rapid pain relief with minimal side effects, improving pediatric procedural care.
Area of Science:
- Pediatric Anesthesiology
- Pharmacology
- Pain Management
Background:
- Effective pain management for pediatric procedures is challenging due to a lack of suitable formulations.
- Current methods range from physical restraint to pharmacological interventions, with limitations in dosing accuracy, acceptance, and onset of action.
Purpose of the Study:
- To evaluate a novel pediatric formulation of intranasal sufentanil and ketamine for procedural pain relief.
- To characterize the pharmacokinetic (PK) profile of this combined nasal spray in children.
Main Methods:
- A prospective, nonrandomized, open-label trial involving 50 children undergoing painful procedures.
- Pain intensity, vital signs, and sedation levels were monitored.
- Pharmacokinetic analysis was performed on a subset of 13 children with central venous access.
Main Results:
- The sufentanil/ketamine nasal spray was effective in 78% of procedures, with 94% of children accepting the spray.
- Vital signs remained stable, and sedation was minimal.
- Pharmacokinetic analysis revealed sufentanil bioavailability of 24.6% and ketamine bioavailability of 35.8%, with rapid Tmax values for both drugs.
Conclusions:
- Intranasal sufentanil/ketamine provides rapid analgesia for pediatric procedural pain.
- The formulation demonstrates a favorable safety profile with few adverse effects.
- This nasal spray presents a promising option for improving pediatric procedural pain management.
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.
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