Overview

Morphine PK Subgroup Analysis

Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Treatments:
Ketorolac Tromethamine
Morphine
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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