Pain Medicine for Wound Care Procedures
The Effectiveness of Small Doses of Ketamine With Morphine on Decreasing Pain Responses During Open Wound Care
1 other identifier
interventional
12
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2008
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 18, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
March 26, 2024
CompletedMarch 26, 2024
March 1, 2024
10 months
June 18, 2008
February 7, 2024
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Intensity
The degree of pain described by participants on a numeric rating scale of 0 to 10, where 0 = no pain and 10 = worst pain imaginable
Immediately after the wound care procedure
Secondary Outcomes (1)
Wound Pain Quality
Immediately after the procedure
Study Arms (2)
Morphine plus Ketamine, then Morphine plus Saline (placebo)
ACTIVE COMPARATORDuring the first wound care procedure, patients received morphine 0.05 mg/kg (a maximum dose of 4 mg) plus ketamine 0.25 mg/kg (MK). Then, during the second wound care procedure, patients received morphine 0.1 mg/kg (a maximum dose of 8 mg) plus saline (MS).
Morphine plus Saline (placebo), then Morphine plus Ketamine
PLACEBO COMPARATORDuring the first wound care procedure, patients received morphine 0.1 mg/kg (a maximum dose of 8 mg) plus saline (MS). Then, during the second wound care procedure, patients received morphine 0.05 mg/kg (a maximum dose of 4mg) plus ketamine 0.25 mg/kg (MK)
Interventions
Morphine 0.05 mg/kg (maximum dose of 4 mg) IV plus Ketamine 0.25 mg/kg IV. Then, Morphine 0.1 mg/kg (maximum dose of 8 mg) IV plus Saline IV
Morphine 0.1 mg/kg (maximum dose of 8 mg) IV plus Saline IV. Then, Morphine 0.05 mg/kg (maximum dose of 4 mg) IV plus Ketamine 0.25 mg/kg IV.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of California San Francisco
San Francisco, California, 94143-0610, United States
Trauma Hospital Puerto Rico Medical Center
San Juan, Puerto Rico
Related Publications (1)
Arroyo-Novoa CM, Figueroa-Ramos MI, Miaskowski C, Padilla G, Paul SM, Rodriguez-Ortiz P, Stotts NA, Puntillo KA. Efficacy of small doses of ketamine with morphine to decrease procedural pain responses during open wound care. Clin J Pain. 2011 Sep;27(7):561-6. doi: 10.1097/AJP.0b013e318211936a.
PMID: 21436683RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The sample size was small, and all patients were male. Blinding was challenging to assure when patients demonstrated adverse effects associated with ketamine. In addition, because different orthopedic technicians performed the WCPs, the effect of the variability in the procedure technique on pain could not be controlled.
Results Point of Contact
- Title
- Dr. Kathleen Puntillo, RN, PhD
- Organization
- University of California, San Francisco
Study Officials
- STUDY CHAIR
Kathleen A Puntillo, RN, DNSc
Regents of the University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2008
First Posted
June 19, 2008
Study Start
June 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
March 26, 2024
Results First Posted
March 26, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share