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

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.