Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children
- Registration Number
- NCT01047241
- Lead Sponsor
- Danish University of Pharmaceutical Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- Allergy to sufentanil or ketamine
- Abnormal nasal cavity
- Have been treated with sufentanil and/or ketamine during the last 48 hours
- Nasal obstruction (rhinitis)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intranasal sufentanil/ketamine Intranasal sufentanil/ketamine Intranasal combination of sufentanil and ketamine. Dose of sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
- Primary Outcome Measures
Name Time Method Bioavailability of Sufentanil and Ketamine Time= 5-60 min after administration of the investigational medical product Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine Time=5-60 min after administration of investigational medicinal product Procedural Pain Intensity Score Pain assessment during painful medical procedure 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= 5-60 min after administration of the investigational medical product
- Secondary Outcome Measures
Name Time Method Acceptance of Intranasal Administration Immediately after the procedure 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?
Sedation Score (UMSS) Time= 0-70 min. after drug administration University of Michigan Sedation Score (UMSS) (0-4, 0 "awake and alert", 4 "unarousable")
Trial Locations
- Locations (1)
Copenhagen University Hospital Rigshospitalet
🇩🇰Copenhagen, Denmark