Morphine PK Subgroup Analysis

NCT01322191 | Completed Phase 4

• 1 other identifier: 10920
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Post Operative Pain

Keywords

pain, pain management, pediatrics, morphine pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Chemical analysis of the plasma and urine samples for morphine concentration using high performance liquid chromatography coupled to atmospheric pressure ionization mass spectrometry

  2 hours

Secondary Outcomes (2)

• Pharmacokinetic analysis of morphine, M3G, and M6G in urine to determine clearance and percent of dose excreted

  2 hours

• Analgesic efficacy using drug concentration and area under the curve ratio correlated with the level of analgesia measured with the age-appropriate scale

  6 months to 1 year

Study Arms (1)

1

EXPERIMENTAL

Random assignment to a single dose of morphine 0.1 mg/kg infused by syringe pump over 10 minutes; urine and blood sample frozen at -80 degrees Celsius

Drug: Morphine

Interventions

Morphine DRUG

A single dose of morphine 0.1 mg/kg infused by syringe pump over 10 minutes; urine and blood sample frozen at -80 degrees Celsius

1

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

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

Study Sites (2)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain; Agnosia

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Robert Ward, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Mary Lieh-Lai, MD

  Children's Hospital of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 24, 2011
• Study Start: April 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 29, 2012

Record last verified: 2008-03

Locations

US (2)