Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children

Conditions
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Pain

Intervention / Treatment
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* Drug: Intranasal sufentanil/ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Allergy to sufentanil or ketamine Abnormal nasal cavity Have been treated with sufentanil and/or ketamine during the last 48 hours Nasal obstruction (rhinitis)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal sufentanil/ketamine<br>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<br>* Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Pain Intensity Score | 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). | Pain assessment during painful medical procedure | 
| Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine |  | Time= 5-60 min after administration of the investigational medical product | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation Score (UMSS) | University of Michigan Sedation Score (UMSS) (0-4, 0 awake and alert, 4 unarousable) | Time= 0-70 min. after drug administration | 
| Acceptance of Intranasal Administration | 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? | Immediately after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Painful medical procedures