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

NCT01900847 | Terminated Results

• 1 other identifier: 13-0045
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Keywords

Ketamine; Acute Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• Number of Participants With Adverse Events

  Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)

Study Arms (2)

Morphine and placebo

ACTIVE COMPARATOR

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

Drug: Morphine; Drug: placebo

Morphine and Ketamine

EXPERIMENTAL

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

Drug: Ketamine; Drug: Morphine

Interventions

Ketamine DRUG

0.3mg/kg ketamine

Morphine and Ketamine

Morphine DRUG

Dosage of morphine determined by treating physician

Morphine and Ketamine; Morphine and placebo

placebo DRUG

saline of same volume as appropriate weight based dose of ketamine

Morphine and placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting to Emergency Department in acute pain
• age 18 and over
• determined to require morphine for pain control by treating physician

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• American College of Emergency Physicians: collaborator

Study Sites (1)

University of Arizona Health Network University Campus 1501 North Campbell Ave

Tucson, Arizona, 85724, United States

Location

Related 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.

  BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Ketamine; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Jaiva Larsen
• Organization: University of Arizona

jlarsen@aemrc.arizona.edu

5039396612

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 17, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 17, 2023
• Results First Posted: July 17, 2023

Record last verified: 2023-07

Locations

US (1)