Pain Clinical Trial
Official title:
Low Dose Ketamine Versus Morphine for Moderate to Severe Pain in the Emergency Department: A Prospective, Randomized, Double-Blind Study
Verified date | October 2015 |
Source | Maimonides Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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), |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Maimonides Medical Center | Brooklyn | New York |
Lead Sponsor | Collaborator |
---|---|
Antonios Likourezos |
United States,
Galinski M, Dolveck F, Combes X, Limoges V, Smaïl N, Pommier V, Templier F, Catineau J, Lapostolle F, Adnet F. Management of severe acute pain in emergency settings: ketamine reduces morphine consumption. Am J Emerg Med. 2007 May;25(4):385-90. — View Citation
Gurnani A, Sharma PK, Rautela RS, Bhattacharya A. Analgesia for acute musculoskeletal trauma: low-dose subcutaneous infusion of ketamine. Anaesth Intensive Care. 1996 Feb;24(1):32-6. — View Citation
Javery KB, Ussery TW, Steger HG, Colclough GW. Comparison of morphine and morphine with ketamine for postoperative analgesia. Can J Anaesth. 1996 Mar;43(3):212-5. — View Citation
Lester L, Braude DA, Niles C, Crandall CS. Low-dose ketamine for analgesia in the ED: a retrospective case series. Am J Emerg Med. 2010 Sep;28(7):820-7. doi: 10.1016/j.ajem.2009.07.023. Epub 2010 Apr 2. — View Citation
Winterfield RW, Fadly AM, Hoerr FJ. Vaccination and revaccination with a Holland (H) strain of infectious bronchitis virus. Avian Dis. 1976 Apr-Jun;20(2):369-74. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric Rating Scale of Pain | We will compare efficacy as a difference between 2 groups in pain score at 30 minutes post-analgesic administration. The primary outcome is the difference between 2 groups in pain score at 30 minutes. Pain will be measured via Numeric rating scale from 0 to 10 with 0 being no pain, 5 being moderate pain, and 10 being severe pain |
30 minutes | Yes |
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