Phase 3
N=12
Pain Medicine for Wound Care Procedures
Wound Care · Pain Intensity · Hyperalgesia · Nausea · Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT00701909 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Pain Intensity — 3.1; 6.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Morphine plus Ketamine (Drug); Morphine plus Saline (placebo) (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity |
3.1; 6.8 | — |
| SECONDARY Wound Pain Quality |
13.6; 17.6 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00701909). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.