CompletedPhase 4ketamine

Low Dose Ketamine Versus Morphine for Moderate to Severe Pain in the Emergency Department

Sponsored by Antonios Likourezos

NCT ID
NCT01835262
Target Enrollment
90 participants
Start Date
2013-04
Est. Completion
2014-05

About This Study

The primary objectives of the study are to evaluate the efficacy of subdissociative dose intravenous ketamine compared with intravenous morphine in relieving acute pain in the ED. Secondary objectives will include the rate of adverse effects and need for rescue analgesia. The hypothesis is that intravenous administration of subdissociative dose ketamine at 0.3 mg/kg is superior to intravenous morphine at 0.1mg/kg in treating moderate and severe acute pain in patients presenting to the ED.

Conditions Studied

Pain

Interventions

  • Morphine
  • Ketamine

Eligibility

Age:18 Years - 55 Years
Healthy Volunteers:Yes
View full eligibility criteria
Inclusion Criteria:

1. ED patients18-55 years old presenting with moderate to severe (Numeric Pain Rating Score \>5) acute (less than 7 days)
2. abdominal, flank, back or musculoskeletal pain warranting (in the treating physician's judgment) administration of intravenous opioid pain medication.
3. Patients must be awake, alert and oriented to time, place and person,
4. patient must be able to demonstrate understanding of the informed consent.
5. Patient must be able to verbalize how much pain they are having on the 10 point Numeric Rating Pain Scale,
6. Patient mus be able to verbalize the nature of the side effects he may be experiencing from the intravenous analgesia.

Exclusion Criteria:

1. Pregnancy or breast feeding
2. SBP\<90
3. Weight greater than 115kg or less than 45kg,
4. altered mental status,
5. allergy to ketamine or morphine,
6. history of acute head or ocular trauma
7. presence of intracranial mass or vascular lesion, presence of psychiatric history
8. diagnosis or treatment (as assessed by electronic chart review).
9. history of seizure or intracranial hypertension
10. history of chronic pain, pain syndrome or fibromyalgia
11. presence of cardiovascular disease except controlled hypertension
12. history of acute head or ocular trauma, drug or alcohol abuse in the preceding 6 months
13. drugs or alcohol abuse in the preceding 6 months
14. SBP\>180
15. HR\<50
16. HR\>150
17. RR\<10
18. RR\>30
19. administration of opiate pain medication in the past 4 hours prior to assessment (i.e. home, EMS, triage, office, etc.)
20. presence of renal or hepatic insufficiency (as assessed by electronic chart review),

Study Locations (1)

Maimonides Medical Center
Brooklyn, New York, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source