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.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children|
- Procedural Pain Intensity Score [ Time Frame: Pain assessment during painful medical procedure ] [ Designated as safety issue: No ]Children <5 years old were administered the FLACC (Face Leg Activity Cry Consolability) Scale (Range: 0-10, where 0 is no pain and 10 is worst pain). Children >= 5 years but < 8 years old were administered the Visual analog scale modified with six faces by Wong-Baker (Wong-Baker Faces Pain Rating Scale) (Range: 0-10, where 0 is no pain and 10 is worst pain). Children >= 8 years old were administered a Visual Analog Scale (Range: 0-10, where 0 is no pain and 10 is worst pain).
- Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine [ Time Frame: Time= 5-60 min after administration of the investigational medical product ] [ Designated as safety issue: No ]
- Bioavailability of Sufentanil and Ketamine [ Time Frame: Time= 5-60 min after administration of the investigational medical product ] [ Designated as safety issue: No ]
- Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine [ Time Frame: Time=5-60 min after administration of investigational medicinal product ] [ Designated as safety issue: No ]
- Sedation Score (UMSS) [ Time Frame: Time= 0-70 min. after drug administration ] [ Designated as safety issue: Yes ]University of Michigan Sedation Score (UMSS) (0-4, 0 "awake and alert", 4 "unarousable")
- Acceptance of Intranasal Administration [ Time Frame: Immediately after the procedure ] [ Designated as safety issue: No ]Asking the children (parents for preverbal children) if they would like to receive this treatment again in a similar situation rather than analgesic suppositories, tablets, oral solutions, or injections?
|Study Start Date:||April 2010|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Intranasal sufentanil/ketamine
Intranasal combination of sufentanil and ketamine. Dose of sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
Drug: Intranasal sufentanil/ketamine
Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047241
|Copenhagen University Hospital Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Steen W Henneberg, MD DMSc||Rigshospitalet, Denmark|
|Principal Investigator:||Kjeld Schmiegelow, MD DMSc||Copenhagen University Hospital Righospitalet|