Other Acute Postoperative Pain, Prolonged Endotracheal Intubation
Conditions
Keywords
Acute Pain, Opioid, Analgesia
Brief summary
The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy of intravenous (IV) buprenorphine in pediatric patients.
Detailed 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.
Interventions
DRUGBuprenorphine IV
Buprenorphine IV administered via patient-controlled analgesia (PCA) pump for at least 24 hours and up to 72 hours.
Sponsors
Purdue Pharma LP
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| The number of participants with adverse events as a measure of safety. | Up to 10 days |
Outcome results
None listed