Geriatric Ketamine for Pain Management Study

NCT02673372 | Completed Phase 4 Results

• 1 other identifier: 2015-10-14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research project is geared towards geriatric analgesia in the Emergency Department (ED) with a goal of reducing the administration of opioid pain medications to elderly patients, thereby avoiding the commonly occurring, severe side effects associated with such medications, including hypotension, respiratory depression, altered mental status, delirium, as well as nausea/vomiting and constipation. The primary outcome of the study will be difference in pain score from baseline to 30 minutes post-medication administration. This project has the potential to change and modify the ED approach to geriatric analgesia by virtue of minimizing the use of opioid administration in elderly patients. T

Conditions

Pain

Keywords

Geriatric, Pain, Ketamine, Emergency Medicine

Outcome Measures

Primary Outcomes (1)

• Reduction of Pain Score at 30 Minutes

  The primary outcome will be the comparative reduction of NRS pain scores between the 2 groups at 30 minutes. The NRS Pain scale ranges from 0 to 10 (0 being no pain at all to 10 being very severe pain; 5 is moderate pain)

  30 minutes

Study Arms (2)

Morphine Group

ACTIVE COMPARATOR

intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg.

Drug: Morphine

Ketamine Group

EXPERIMENTAL

Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min)

Drug: Ketamine

Interventions

Morphine DRUG

intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. The device is the Care Fusion Alaris PC.

Morphine Group

Ketamine DRUG

Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min). The device is the Care Fusion Alaris PC.

Ketamine Group

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ED patients; 65 years of age and older; abdominal, flank, back, traumatic chest, neck or musculoskeletal pain; capacity to give verbal or written consent.

You may not qualify if:

• ED patients \<65 years old; altered mental status; presenting with headache, non-traumatic chest pain; allergy to morphine or ketamine; weight \<40kg or \>115kg, unstable vital signs (systolic blood pressure \<90 or \>180 mmHg; heart rate \<5 or \>150 beats per minute; and respirations \<8 or \>30 per minute), and past medical history of severe renal or hepatic insufficiency, alcohol or drug abuse or psychiatric illness; Patients with BMI\>40; severe COPD

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (20)

• Gibson SJ. Pain and ageing: a comparison of the pain experience over the adult life span. Prog Pain Res Manage. 2003;24:767-90.

  BACKGROUND

• Gibson SJ, Farrell M. What is different about pain in older people? Reviews in Analgesia. 2004;8:23-37.

  BACKGROUND

• Gibson SJ. Older Persons' Pain: what can we learn? Pain Clin Updat. 2006;14:1-4.

  BACKGROUND

• American Geriatrics Society Panel on the Pharmacological Management of Persistent Pain in Older Persons. Pharmacological management of persistent pain in older persons. Pain Med. 2009 Sep;10(6):1062-83. doi: 10.1111/j.1526-4637.2009.00699.x. Epub 2009 Sep 9. No abstract available.

  PMID: 19744205 BACKGROUND

• Leveille SG, Jones RN, Kiely DK, Hausdorff JM, Shmerling RH, Guralnik JM, Kiel DP, Lipsitz LA, Bean JF. Chronic musculoskeletal pain and the occurrence of falls in an older population. JAMA. 2009 Nov 25;302(20):2214-21. doi: 10.1001/jama.2009.1738.

  PMID: 19934422 BACKGROUND

• Linnebur SA, O'Connell MB, Wessell AM, McCord AD, Kennedy DH, DeMaagd G, Dent LA, Splinter MY, Biery JC Jr, Chang F, Jackson RC, Miller SL, Sterling T; ACCP Task Force. Pharmacy practice, research, education, and advocacy for older adults. Pharmacotherapy. 2005 Oct;25(10):1396-430. doi: 10.1592/phco.2005.25.10.1396.

  PMID: 16185185 BACKGROUND

• Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, Weisner CM, Silverberg MJ, Campbell CI, Psaty BM, Von Korff M. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med. 2010 Jan 19;152(2):85-92. doi: 10.7326/0003-4819-152-2-201001190-00006.

  PMID: 20083827 BACKGROUND

• Solomon DH, Rassen JA, Glynn RJ, Lee J, Levin R, Schneeweiss S. The comparative safety of analgesics in older adults with arthritis. Arch Intern Med. 2010 Dec 13;170(22):1968-76. doi: 10.1001/archinternmed.2010.391.

  PMID: 21149752 BACKGROUND

• Domino EF. Taming the ketamine tiger. 1965. Anesthesiology. 2010 Sep;113(3):678-84. doi: 10.1097/ALN.0b013e3181ed09a2.

  PMID: 20693870 BACKGROUND

• Strigo IA, Duncan GH, Bushnell CM, Boivin M, Wainer I, Rodriguez Rosas EM, Persson J. The effects of racemic ketamine on painful stimulation of skin and viscera in human subjects. Pain. 2005 Feb;113(3):255-264. doi: 10.1016/j.pain.2004.10.023.

  PMID: 15661431 BACKGROUND

• Smith DC, Mader TJ, Smithline HA. Low dose intravenous ketamine as an analgesic: a pilot study using an experimental model of acute pain. Am J Emerg Med. 2001 Oct;19(6):531-2. doi: 10.1053/ajem.2001.27152. No abstract available.

  PMID: 11593484 BACKGROUND

• Sadove MS, Shulman M, Hatano S, Fevold N. Analgesic effects of ketamine administered in subdissociative doses. Anesth Analg. 1971 May-Jun;50(3):452-7. No abstract available.

  PMID: 5103784 BACKGROUND

• Schmid RL, Sandler AN, Katz J. Use and efficacy of low-dose ketamine in the management of acute postoperative pain: a review of current techniques and outcomes. Pain. 1999 Aug;82(2):111-125. doi: 10.1016/S0304-3959(99)00044-5.

  PMID: 10467917 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

• Jennings PA, Cameron P, Bernard S, Walker T, Jolley D, Fitzgerald M, Masci K. Morphine and ketamine is superior to morphine alone for out-of-hospital trauma analgesia: a randomized controlled trial. Ann Emerg Med. 2012 Jun;59(6):497-503. doi: 10.1016/j.annemergmed.2011.11.012. Epub 2012 Jan 13.

  PMID: 22243959 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

• Ahern 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: 25643741 BACKGROUND

• Beaudoin FL, Lin C, Guan W, Merchant RC. Low-dose ketamine improves pain relief in patients receiving intravenous opioids for acute pain in the emergency department: results of a randomized, double-blind, clinical trial. Acad Emerg Med. 2014 Nov;21(11):1193-202. doi: 10.1111/acem.12510.

  PMID: 25377395 BACKGROUND

• Motov S, Rockoff B, Cohen V, Pushkar I, Likourezos A, McKay C, Soleyman-Zomalan E, Homel P, Terentiev V, Fromm C. Intravenous Subdissociative-Dose Ketamine Versus Morphine for Analgesia in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2015 Sep;66(3):222-229.e1. doi: 10.1016/j.annemergmed.2015.03.004. Epub 2015 Mar 26.

  PMID: 25817884 BACKGROUND

• Motov S, Mann S, Drapkin J, Butt M, Likourezos A, Yetter E, Brady J, Rothberger N, Gohel A, Flom P, Mai M, Fromm C, Marshall J. Intravenous subdissociative-dose ketamine versus morphine for acute geriatric pain in the Emergency Department: A randomized controlled trial. Am J Emerg Med. 2019 Feb;37(2):220-227. doi: 10.1016/j.ajem.2018.05.030. Epub 2018 May 16.

  PMID: 29807629 DERIVED

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

Results Point of Contact

• Title: Sergey Motov, Director of Research
• Organization: Maimonides Medical Center

smotov@maimonidesmed.org

718-283-8693

Study Officials

• Sergey Motov, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: February 1, 2016
• First Posted: February 3, 2016
• Study Start: April 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 31, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)