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

Study Overview
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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.

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.

Official Title
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A Multicenter, Inpatient, Open-label Study to Characterize the Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Aged From Birth to 6 Years of Age (Inclusive) Who Require Opioid Analgesia for Acute Moderate to Severe Pain

Conditions
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Other Acute Postoperative Pain, Prolonged Endotracheal Intubation

Intervention / Treatment
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* Drug: Buprenorphine IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria include: 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 include: 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 Are deemed to be unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria. Other protocol-specific inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buprenorphine IV<br>Buprenorphine IV | Drug: Buprenorphine IV<br>* Buprenorphine IV administered via patient-controlled analgesia (PCA) pump for at least 24 hours and up to 72 hours.<br>* Other names: Buprenex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measures are clearance (CL/F) and apparent central volume of distribution (Vc/F) estimated using standard population nonlinear mixed effects methodology. |  | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with adverse events as a measure of safety. |  | Up to 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Pain, Opioid, Analgesia