Morphine PK Subgroup Analysis

Completed · Phase 4

Conditions studied: Post Operative Pain

In brief

This study was originally undertaken to evaluate the analgesic efficacy of an intravenously administered dose of ketorolac compared with intravenous morphine in the relief of acute, postoperative pain in children admitted to the Intensive Care Unit. Using the urine and plasma samples originally collected from patients in the morphine treatment group and which were never analyzed, this proposal seeks to study the pharmacokinetics and metabolism of intravenous morphine in critically-ill children along with its concentration-related efficacy using prior measures of pain.

Key facts

Study ID

NCT01322191

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

48

Starts

2008-04-01

Expected to finish

2010-11-01

Last updated by the study team

2012-10-29

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All children 3-18 years of age admitted to the ICU at Children's Hospital of Michigan postoperatively who required pain management during the immediate postoperative period
• Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and/or Oucher pain score meeting the protocol definition of moderate to severe pain

You may not qualify if…

• Coma (Glasgow Coma Score < 8) or significant post-operative sedation that prevented the patient from appropriate responses to questions
• Requirement of administration of a sedative or neuromuscular blocking agent, or intrathecal narcotics immediately after surgery
• Gastrointestinal hemorrhage and/or history of ulcer disease
• Frequent use of NSAIDs or narcotic analgesics for >2 weeks within the 1-month period before the study
• Asthma
• Known hypersensitivity to NSAIDs, aspirin or opiates
• Nephrotic syndrome or acute/chronic renal failure
• Thrombocytopenia (platelet count <100,000)
• Congestive heart failure
• Hepatic failure
• Treatment with methotrexate, thiazides, β-blocking agents or warfarin at the time of the study
• Dehydration or hypovolemia

Where it is running

• Children's Hospital of Michigan — Detroit, Michigan, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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