Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Who Require Opioid Analgesia for Acute Moderate to Severe Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-08-31

Brief Summary

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The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy of intravenous (IV) buprenorphine in pediatric patients.

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Detailed Description

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A study of the PK, safety, and efficacy of IV buprenorphine in acute moderate to severe pain in male and female pediatric patients aged from birth to 6 years, inclusive, requiring continuous opioid analgesic treatment for at least 24 hours and up to 72 hours.

Conditions

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Other Acute Postoperative Pain Prolonged Endotracheal Intubation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Buprenorphine IV

Group Type EXPERIMENTAL

Buprenorphine IV

Intervention Type DRUG

Buprenorphine IV administered via patient-controlled analgesia (PCA) pump for at least 24 hours and up to 72 hours.

Interventions

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Buprenorphine IV

Buprenorphine IV administered via patient-controlled analgesia (PCA) pump for at least 24 hours and up to 72 hours.

Intervention Type DRUG

Other Intervention Names

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Buprenex

Eligibility Criteria

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Inclusion Criteria

* Must have written informed consent provided by the parent or legal guardian and/or patient assent, when appropriate
* Male and female children, from birth to aged 6 years, inclusive, with minimum weight of 2.5 kg
* Have or are anticipated to have acute moderate to severe pain; requiring treatment with an intravenous (IV) opioid analgesic medication for at least 24 hours postoperatively or; due to prolonged endotracheal intubation requiring IV opioid analgesic treatment for at least 24 hours poststabilization
* Must have stable vital signs
* Must have stable respiratory status
* Must be inpatient for the treatment period of the study

Exclusion Criteria

* Have any known allergy or sensitivity to buprenorphine or other opioids (this criterion does not include patients who have experienced common opioid side effects \[eg, nausea, constipation\])
* Have evidence of impaired renal function
* Have hepatic impairment
* Have history of seizures
* Have a history of sleep apnea within the past year
* Have structural heart disease or a pacemaker
* Have clinically unstable cardiac disease
* Have used any investigational medication/therapy within 30 days prior to the first dose of study drug

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No