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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-02-28

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.

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Procedural Pain

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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.

Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intranasal sufentanil/ketamine

Intranasal combination of sufentanil and ketamine. Dose of sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.

Group Type EXPERIMENTAL

Intranasal sufentanil/ketamine

Intervention Type DRUG

Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose

Interventions

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Intranasal sufentanil/ketamine

Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose

Intervention Type DRUG

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)

Minimum Eligible Age

1 Year

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No