The Effectiveness of Small Doses of Ketamine With Morphine on Decreasing Pain Responses During Open Wound Care

H2280-32187-01

This is a randomized double-blind study to determine if the administration of a small-dose of ketamine (an anesthetic)added to morphine (an opioid) contributes to reducing pain intensity during open wound care procedure (WCP)in patients who have had a traumatic injury and are in an Intensive Care Unit. Patients will be randomized to receive morphine plus saline (a placebo) or morphine plus ketamine before the WCP. The second time the patient is scheduled for WCP (no less than 24 hours), patients will be crossed over to receive the treatment they did not receive the first time. It is hypothesized that patients who receive the combination of morphine and ketamine will have better pain control during the procedure than patients who just receive morphine.

2008-06-01

2009-04-01

2009-04-01

Completed

Early phase I

12

Inclusion Criteria: * Adults patients (≥ 21 years) have to have an open wound with duration of no more than 10 days that requires wound care * be able to self-report their pain * had a pain intensity score \> 3 during previous wound care procedure * has intravenous access Exclusion Criteria: * Patients with an injury that impairs sensation in the wound area according to a medical diagnosis * has an allergy to morphine or ketamine * has not received morphine previously * In addition, patients who are 65 years of age or older.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}

2024-03-26