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

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01900847
• Other study ID #: 13-0045
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2013
• Est. completion date: April 1, 2014

Study information

• Verified date: July 2023
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: April 1, 2014
• Est. primary completion date: April 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Emergencies

Intervention

Drug:
• Ketamine
0.3mg/kg ketamine
• Morphine
Dosage of morphine determined by treating physician
• placebo
saline of same volume as appropriate weight based dose of ketamine

Locations

Country	Name	City	State
United States	University of Arizona Health Network University Campus 1501 North Campbell Ave	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Arizona College of Emergency Physicians

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Score	Pain 0-10 with 0 being no pain and 10 being the worst pain	Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug
Secondary	Total Amount of Morphine and Other Pain Medications Administered		Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)
Secondary	Number of Participants With Adverse Events		Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)