Clinical trial

Ketamine and Morphine Versus Morphine Alone for the Treatment of Acute Pain in the Emergency Department

Name
13-0045
Description
Our goal is to study whether giving people low dose ketamine along with morphine when they come to the Emergency Department will help their pain more than giving morphine by itself. There have been many studies showing that low dose ketamine is safe and effective for pain control. Ketamine is frequently used for pain control in ambulances and helicopters transporting injured patients to the hospital and has also been used for pain control in people who have just had surgery. The investigators would like to see if low dose ketamine would be safe and effective for patients with pain in the Emergency Department. Patients are eligible for the study if they come to the Emergency Department and their treating physician decides to treat them with morphine (with certain exceptions such as pregnant patients and patients with eye injuries). They will be given information about participating in the study and if they agree, they will be given the study drug. The study drug will be either ketamine or salt water (saline). If patients continue to be in pain they will continue to receive doses of morphine just as they would if they were not in the study. If the treating physician feels that morphine alone is not enough, they will be free to choose another pain medication as they would normally.
Trial arms
Trial start
2013-06-01
Estimated PCD
2014-04-01
Trial end
2014-04-01
Status
Terminated
Treatment
Ketamine
0.3mg/kg ketamine
Arms:
Morphine and Ketamine
Morphine
Dosage of morphine determined by treating physician
Arms:
Morphine and Ketamine, Morphine and placebo
placebo
saline of same volume as appropriate weight based dose of ketamine
Arms:
Morphine and placebo
Size
17
Primary endpoint
Numeric Pain Score
Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug
Eligibility criteria
Inclusion Criteria: * Presenting to Emergency Department in acute pain * age 18 and over * determined to require morphine for pain control by treating physician Exclusion Criteria: * Patients presenting with headache or head injury * Patient with eye injury or eye pain * Nontraumatic chest Pain * Pregnant patients or women of childbearing potential * Patients allergic to morphine or ketamine * Patients with known history of narcotic/alcohol abuse or presenting for narcotic medication refill * Patients with hypertension: diastolic blood pressure \> 100 OR systolic blood pressure \> 180 * Patient whose pain is so severe that they are unable to give informed consent * Patients who have had bad experiences to prior hallucinations from any origin
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 17, 'type': 'ACTUAL'}}
Updated at
2023-07-17

1 organization

1 product

2 drugs

1 indication

Indication
Pain
Product
Morphine