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

Purdue Pharma

Status and phase

Withdrawn

Phase 3

Conditions

Prolonged Endotracheal Intubation

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

Under 6 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.