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

NCT ID: NCT01900847

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-01
• Study Completion Date: 2014-04-01

Brief Summary

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.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Morphine and placebo

Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

Dosage of morphine determined by treating physician

placebo

Intervention Type: DRUG

saline of same volume as appropriate weight based dose of ketamine

Morphine and Ketamine

Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

0.3mg/kg ketamine

Morphine

Intervention Type: DRUG

Dosage of morphine determined by treating physician

Interventions

Ketamine

0.3mg/kg ketamine

Intervention Type: DRUG

Morphine

Dosage of morphine determined by treating physician

Intervention Type: DRUG

placebo

saline of same volume as appropriate weight based dose of ketamine

Intervention Type: 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American College of Emergency Physicians

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Arizona Health Network University Campus 1501 North Campbell Ave

Tucson, Arizona, United States

Countries

United States

References

Berkman, M. R., Larsen, J., Smith, J., Caldwell, J., Waterbrook, A., Stolz, U., & Denninghoff, K. (2014). 369 Ketamine and Morphine versus Morphine Alone for Treatment of Acute Pain in the Emergency Department. Annals of Emergency Medicine, 64(4), S131-S132.

Reference Type: BACKGROUND

Other Identifiers

13-0045

Identifier Type: -

Identifier Source: org_study_id