Clinical trial NCT01047241: Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children
Official title: Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Painful medical procedures
Lead sponsor: Danish University of Pharmaceutical Sciences
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2010-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Procedural Pain Intensity Score
timeFrame: Pain assessment during painful medical procedure
measure: Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine
timeFrame: Time= 5-60 min after administration of the investigational medical product
measure: Bioavailability of Sufentanil and Ketamine
timeFrame: Time= 5-60 min after administration of the investigational medical product
measure: Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine
timeFrame: Time=5-60 min after administration of investigational medicinal product
Secondary outcomes:
measure: Sedation Score (UMSS)
timeFrame: Time= 0-70 min. after drug administration
measure: Acceptance of Intranasal Administration
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Steen W Henneberg, MD DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Copenhagen University Hospital Righospitalet
name: Kjeld Schmiegelow, MD DMSc
role: PRINCIPAL_INVESTIGATOR
References: