Pain Medicine for Wound Care Procedures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00701909
First received: June 18, 2008
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Wound Care
Pain Intensity
Hyperalgesia
Nausea
Vomiting
Hallucinations
Drug: morphine plus saline
Drug: morphine plus ketamine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effectiveness of Small Doses of Ketamine With Morphine on Decreasing Pain Responses During Open Wound Care

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • pain intensity [ Time Frame: immediately after the wound care procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hyperalgesia [ Time Frame: immediately after the procedure ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: June 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
During the first wound care procedure, patients will receive either morphine 0.1 mg/kg (maximum dose of 8 mg) plus saline (MS) or morphine 0.05 mg/kg (maximum dose of 4 mg) plus ketamine 0.25 mg/kg (MK) before the WCP according to randomization. During the second wound care procedure, they will receive the drugs and doses that they had not received the first time.
Drug: morphine plus saline
During the first wound care procedure, some patients will receive morphine 0.1 mg/kg (maximum dose of 8 mg) plus saline (MS), according to randomization, while other patients will receive morphine 0.05 mg/kg (maximum dose of 4 mg) plus ketamine 0.25 mg/kg
Active Comparator: 2
During the second wound care procedure, patients will receive either morphine 0.1 mg/kg (maximum dose of 8 mg) plus saline (MS) or morphine 0.05 mg/kg (maximum dose of 4 mg) plus ketamine 0.25 mg/kg (MK), whichever drugs and doses that they had not received the first time.
Drug: morphine plus ketamine
Patients who received morphine 0.1 mg/kg (maximum dose of 8 mg)plus saline during the first wound care procedure will now receive ketamine 0.25 mg/kg IV plus morphine 0.05 mg/kg

Detailed Description:

An open wound care procedure causes pain and sometimes the use of medication such as morphine alone does not adequately help to alleviate pain during this procedure. This study is being done to learn if the administration of another medication named ketamine by the vein in addition to morphine is more effective in alleviating pain during the wound cleansing procedure than the administration of morphine alone. Patients will be eligible for the study if they are 21 years and older, have an open surgical or traumatic wound with a duration of no more than 10 days, had a wound pain intensity score more than 3 in a scale of 0 to 10 where 0 is no pain and 10 is the worst pain imaginable during a previous wound care procedure, and have an intravenous access.

A total of 50 patients with these same characteristics are expected to take part in this study. Patients who agree to take part in this study will, one day, receive receive an injection via the vein of morphine 0.05 mg per kilogram of their weight (maximum dose of 4 mg) and another of ketamine 0.25 mg per kilogram of their weight prior receiving the wound care procedure and, on the other day, will receive an injection via the vein of morphine 0.1 mg per kilogram of their weight (maximum dose of 8 mg) and another of saline prior receiving the wound care procedure. They will not be able to know if they receive ketamine or saline the first time or second time.

Ketamine is a drug approved by the U.S. Food and Drug Administration (FDA) for anesthesia but not approved to provide analgesia (relieve pain). However, small doses of ketamine are used (out of its indications) in the clinical area to provide analgesia, and its analgesic properties have been studied by many researchers.

Before the wound care procedure subjects will be asked to rate their wound pain intensity at rest at that moment and in the past 24 hours (including "worst" and "average" pain), overall pain intensity at rest at this moment and "worst" and "average" in the past 24 hours using a 0 to 10 scale where 0 is no pain and 10 is the worst pain imaginable. They will be given a list of common words that might describe their pain, and a body outline to indicate where the pain is. In addition, they will be asked to rate their level of sleepiness using a 0 to 10 scale where 0 is not at all sleepy and 10 is extremely sleepy.

After removing the outer dressing, patients will be tested for pain sensitivity around the wound with a thin, short length of plastic (like a little straw), which will be pressed against their skin from the outside of the wound towards the wound and they will be asked to report a distinct change in perception. The first point where a "painful", "sore", or "sharper" feeling occurs will be marked in the skin to measure the distance of this mark to the wound. If no change in perception occurs, stimulation will be stopped 0.5 cm from the wound. This measure is experimental.

Immediately after the wound care procedure the following will be measured: (1) "worst" wound pain intensity experienced during the wound care procedure, (2) description of pain quality during the wound care procedure, (3) level of sleepiness, (4) side effects such as unpleasant sensation will be measured using a 0 to 10 scale, where 0 means no unpleasant sensation at all and 10 means extremely unpleasant sensation, and finally (5) pain sensitivity around the wound using a thin, short length of plastic.

The length of time needed to take part in this study will depend on how long the wound care procedure takes. The time could be approximately 45 minutes to 60 minutes (1 hour) per visit and 90 minutes (1½ hour) to 120 minutes (2 hours) in total for the study because 2 days are needed to complete the study.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701909

Locations
Puerto Rico
Trauma Unit University of Puerto Rico Medical Center
San Juan, Puerto Rico
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Chair: Kathleen A Puntillo, RN, DNSc Regents of the University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00701909     History of Changes
Other Study ID Numbers: H2280-32187-01
Study First Received: June 18, 2008
Last Updated: January 14, 2014
Health Authority: United States: UCSF School of Nursing doctoral dissertation committee for Carmen Mabel Arroyo

Keywords provided by University of California, San Francisco:
wound care
procedural pain intensity
procedural hyperalgesia
wound care pain intensity
wound care hyperalgesia
Wound care pain quality
Level of drowsiness
level of nausea
Level of vomiting
Level of hallucinations
Level of dysphoria

Additional relevant MeSH terms:
Hallucinations
Hyperalgesia
Vomiting
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Perceptual Disorders
Sensation Disorders
Signs and Symptoms
Signs and Symptoms, Digestive
Somatosensory Disorders
Ketamine
Morphine
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Narcotics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on October 23, 2014