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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2013

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.

Interventions

  • Drug: Intranasal sufentanil/ketamine
    • Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Procedural Pain Intensity Score
    • Time Frame: 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 Frame: Time= 5-60 min after administration of the investigational medical product
  • Bioavailability of Sufentanil and Ketamine
    • Time Frame: Time= 5-60 min after administration of the investigational medical product
  • Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine
    • Time Frame: Time=5-60 min after administration of investigational medicinal product

Secondary Measures

  • Sedation Score (UMSS)
    • Time Frame: Time= 0-70 min. after drug administration
    • University of Michigan Sedation Score (UMSS) (0-4, 0 “awake and alert”, 4 “unarousable”)
  • Acceptance of Intranasal Administration
    • Time Frame: 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?

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 19 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Danish University of Pharmaceutical Sciences
  • Collaborator
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bettina Nygaard Nielsen, M.Sc. Pharm. sponsor contact person – Danish University of Pharmaceutical Sciences
  • Overall Official(s)
    • Steen W Henneberg, MD DMSc, Principal Investigator, Rigshospitalet, Denmark
    • Kjeld Schmiegelow, MD DMSc, Principal Investigator, Copenhagen University Hospital Righospitalet

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