DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Danish University of Pharmaceutical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Intranasal sufentanil/ketamine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Danish University of Pharmaceutical Sciences

Official(s) and/or principal investigator(s):
Steen W Henneberg, MD DMSc, Principal Investigator, Affiliation: Rigshospitalet, Denmark
Kjeld Schmiegelow, MD DMSc, Principal Investigator, Affiliation: Copenhagen University Hospital Righospitalet

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.

Clinical Details

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

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

Primary outcome:

Procedural Pain Intensity Score

Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine

Bioavailability of Sufentanil and Ketamine

Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine

Secondary outcome:

Sedation Score (UMSS)

Acceptance of Intranasal Administration

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.

Eligibility

Minimum age: 1 Year. Maximum age: 19 Years. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Copenhagen University Hospital Rigshospitalet, Copenhagen 2100, Denmark
Additional Information

Starting date: April 2010
Last updated: September 12, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017