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

NCT01835262 | Completed Phase 4 Results

• 2 other identifiers: 12/09/VA0112-09-VA01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pain

Keywords

pain; Ketamine; Emergency Medicine; morphine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Morphine

ACTIVE COMPARATOR

Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP

Drug: Morphine

Ketamine Group

EXPERIMENTAL

Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP

Drug: Ketamine

Interventions

Morphine DRUG

Morphine: 0.1 mg /kg given as IVP

Morphine

Ketamine DRUG

Ketamine:0.3 mg/given as IVP

Ketamine Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnancy or breast feeding
• SBP\<90
• Weight greater than 115kg or less than 45kg,
• altered mental status,
• allergy to ketamine or morphine,
• history of acute head or ocular trauma
• presence of intracranial mass or vascular lesion, presence of psychiatric history
• diagnosis or treatment (as assessed by electronic chart review).
• history of seizure or intracranial hypertension
• history of chronic pain, pain syndrome or fibromyalgia
• presence of cardiovascular disease except controlled hypertension
• history of acute head or ocular trauma, drug or alcohol abuse in the preceding 6 months
• drugs or alcohol abuse in the preceding 6 months
• SBP\>180
• HR\<50

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (5)

• 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.

  PMID: 180959 BACKGROUND

• 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. doi: 10.1007/BF03011736.

  PMID: 8829857 BACKGROUND

• 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. doi: 10.1177/0310057X9602400106.

  PMID: 8669651 BACKGROUND

• Galinski M, Dolveck F, Combes X, Limoges V, Smail 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. doi: 10.1016/j.ajem.2006.11.016.

  PMID: 17499654 BACKGROUND

• 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.

  PMID: 20837262 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Morphine; Ketamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

This was a single center study in which patients were enrolled as a convenience. There was the potential for unblinding as some participants exhibited ketamine specific reactions such as nystagmus.

Results Point of Contact

• Title: Antonios Likourezos
• Organization: Maimonides Medical Center

alikourezos@maimonidesmed.org

718-283-6896

Study Officials

• Sergey Motov, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 18, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 29, 2016
• Results First Posted: August 27, 2015

Record last verified: 2015-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)