Ketamine: Comparison of IV Push vs. IV Drip
Comparison of Intravenous Push Dose of Low Dose Ketamine to Short Infusion of Low Dose Ketamine for Treatment of Moderate to Severe Pain in the Emergency Department: A Prospective, Randomized, Double-Blind Study
1 other identifier
interventional
48
1 country
1
Brief Summary
Our previous published research comparing the efficacy of intravenous ketamine to morphine has shown ketamine to provide equivalent relief of moderate to severe acute pain in emergency medicine patients. Secondary analysis of the previous published research has also revealed ketamine to have statistically more side effects. The investigators believe that increasing the time of administration of the ketamine, from a push injection to a drip infusion, will minimize the side effects experienced by recipients of ketamine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Apr 2015
Typical duration for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2015
CompletedFirst Posted
Study publicly available on registry
February 13, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2017
CompletedResults Posted
Study results publicly available
October 2, 2017
CompletedNovember 22, 2017
October 1, 2017
1.4 years
February 9, 2015
March 18, 2017
October 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Rate of Feeling Unreality
Overall rate of feeling of unreality as measured by Side Effects Rating Scale for Dissociative Anesthetics (SERSDA)
30 minutes
Study Arms (2)
IV Push Group
ACTIVE COMPARATORKetamine medication given via IV Push. IV Push is the intervention.
IV Drip Group
ACTIVE COMPARATORKetamine medication given via IV Drip. IV Drip is the intervention.
Interventions
Eligibility Criteria
You may qualify if:
- Emergency Medicine patients
- Adult patients (18-65 years of age)
- Moderate to severe pain (Numeric Pain Rating Score =5).
- Patients must be awake, alert and oriented to time, place and person.
- Patients must be able to demonstrate understanding of the informed consent, and also able to verbalize how much pain they are having on the 10 point Numeric Rating Pain Scale, and the nature of the side effects they may be experiencing from the IV analgesia
You may not qualify if:
- Patients with cognitive deficits that are not able to demonstrate understanding as described above.
- Patient's reported weight of less than 45kg or more than 115kg.
- Patients with altered mental status, alcohol intoxication, eye trauma.
- Patients with hemodynamic instability (Systolic Blood pressure \<90), and malignant hypertension.
- allergy to ketamine
- Pregnancy or breast feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Related Publications (7)
1. Abdullah M. Ketamine. A new look at an old drug. M ABDULLAH. anaesthetics.ukzn.ac.za/.../Ketamine_a_new_look_at_an_old_drug_...(accessed on 12/21/11)
BACKGROUNDJavery 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: 8829857BACKGROUNDLester 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: 20837262BACKGROUNDRichards JR, Rockford RE. Low-dose ketamine analgesia: patient and physician experience in the ED. Am J Emerg Med. 2013 Feb;31(2):390-4. doi: 10.1016/j.ajem.2012.07.027. Epub 2012 Oct 4.
PMID: 23041484BACKGROUNDGurnani 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: 8669651BACKGROUNDGalinski 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: 17499654BACKGROUNDAhern TL, Herring AA, Miller S, Frazee BW. Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain. Pain Med. 2015 Jul;16(7):1402-9. doi: 10.1111/pme.12705. Epub 2015 Feb 3.
PMID: 25643741BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sergey Motov
- Organization
- Maimonides Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Sergey Motov, MD
Maimonides Medical Center
- STUDY CHAIR
John Marshall, MD
Maimonides Medical Center
- STUDY DIRECTOR
Christian Fromm, MD
Maimonides Medical Center
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 INVESTIGATOR
- PI Title
- Research Manager
Study Record Dates
First Submitted
February 9, 2015
First Posted
February 13, 2015
Study Start
April 1, 2015
Primary Completion
August 15, 2016
Study Completion
February 28, 2017
Last Updated
November 22, 2017
Results First Posted
October 2, 2017
Record last verified: 2017-10