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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047241
• Other study ID #: 201010
• Secondary ID: 2009-013801-33
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2010
• Last updated: September 12, 2014
• Start date: April 2010
• Est. completion date: February 2013

Study information

• Verified date: September 2014
• Source: Danish University of Pharmaceutical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 19 Years

Eligibility

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)

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Danish University of Pharmaceutical Sciences	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine		Time= 5-60 min after administration of the investigational medical product	No
Primary	Bioavailability of Sufentanil and Ketamine		Time= 5-60 min after administration of the investigational medical product	No
Primary	Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine		Time=5-60 min after administration of investigational medicinal product	No
Secondary	Sedation Score (UMSS)	University of Michigan Sedation Score (UMSS) (0-4, 0 "awake and alert", 4 "unarousable")	Time= 0-70 min. after drug administration	Yes
Secondary	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	No