Comparing Ketamine and Morphine in the Treatment of Acute Fracture Pain

NCT02430818 | Terminated Results DMC

• 1 other identifier: 201501068
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Opioid pain medications such as morphine and dilaudid are commonly used in emergency departments to treat pain in patients. Physicians are familiar with the side effects of these medications; the most concerning of which is slowing or stopping a patient's breathing, as well as dangerously lowering their blood pressure. An alternative medication is ketamine. This medication is also commonly used in the emergency department, although it is typically used to help sedate patients for uncomfortable procedures. Ketamine has also been used for pain control, but in a much lower dosage that does not sedate patients. When used for analgesia, it has typically been administered in combination with opioid pain medications. To date, there is no study that looks at the effectiveness and safety of using a low dose ketamine alone in comparison to the use of morphine. The purpose of this study is to measure how well low-dose ketamine treats pain compared to morphine and to look at how often serious side effects are seen with each medication.

Conditions

Acute Pain; Fractures

Keywords

ketamine; emergency medicine; orthopedics

Outcome Measures

Primary Outcomes (1)

• Pain Treatment-VAS (Visual Analog Scale)

  Study outcomes involve change in participants' pain as measured by a visual analog scale. The scale is a 10 inch line from 0 to 10 inches with 10 being the most pain and 0 being no pain. There are no units on the scale; it is just a straight line from no pain (0) to the worst pain (10). We assessed at o, 15, and 60 minutes but only scored the VAS at 60 minutes.

  At 0 minutes and 60 minutes

Secondary Outcomes (2)

• Number of Participants With an Adverse Effects

  60 minutes

• Would the Participant Would Consider Using the Drug Given to Them for Pain Relief in the Future

  60 minutes

Study Arms (2)

Ketamine

EXPERIMENTAL

Ketamine is a dissociative agent that is thought to modulate pain by binding to NMDA receptors. Participants assigned to the ketamine arm will be given 0.4 mg/kg IV of ketamine (40 mg maximum).

Drug: ketamine

Morphine

EXPERIMENTAL

Morphine is an opioid that acts on opioidergic receptors to modulate pain. Participants in the opioid arm will receive 0.1 mg/kg IV of morphine (10 mg maximum).

Drug: morphine

Interventions

ketamine DRUG

Ketamine

morphine DRUG

Morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible Long bone fractures. This will include:
• Humerus
• Tibia
• Fibula
• Femur
• Radius
• Ulna

You may not qualify if:

• Injuries older than 24 hours
• Avulsion fractures
• History of substance abuse
• History of chronic opioid dependence
• Pregnancy
• Demonstrates signs of intoxication
• Allergic to ketamine or opioids
• Patients unable to consent
• Hemodynamically unstable (SBP \>180mmHg or \<100mgHg, HR \>130bpm, Respiratory rate \<10, oxygen saturations \<90%

Sponsors & Collaborators

• Washington University School of Medicine: lead
• MOCEP: collaborator

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (19)

• Ahern TL, Herring AA, Stone MB, Frazee BW. Effective analgesia with low-dose ketamine and reduced dose hydromorphone in ED patients with severe pain. Am J Emerg Med. 2013 May;31(5):847-51. doi: 10.1016/j.ajem.2013.02.008. Epub 2013 Apr 18.

  PMID: 23602757 BACKGROUND

• Andolfatto G, Willman E, Joo D, Miller P, Wong WB, Koehn M, Dobson R, Angus E, Moadebi S. Intranasal ketamine for analgesia in the emergency department: a prospective observational series. Acad Emerg Med. 2013 Oct;20(10):1050-4. doi: 10.1111/acem.12229.

  PMID: 24127709 BACKGROUND

• Aubrun F, Langeron O, Quesnel C, Coriat P, Riou B. Relationships between measurement of pain using visual analog score and morphine requirements during postoperative intravenous morphine titration. Anesthesiology. 2003 Jun;98(6):1415-21. doi: 10.1097/00000542-200306000-00017.

  PMID: 12766651 BACKGROUND

• Bell RF, Dahl JB, Moore RA, Kalso E. Perioperative ketamine for acute postoperative pain. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD004603. doi: 10.1002/14651858.CD004603.pub2.

  PMID: 16437490 BACKGROUND

• Bijur PE, Esses D, Chang AK, Gallagher EJ. Dosing and titration of intravenous opioid analgesics administered to ED patients in acute severe pain. Am J Emerg Med. 2012 Sep;30(7):1241-4. doi: 10.1016/j.ajem.2011.06.015. Epub 2011 Sep 9.

  PMID: 21908134 BACKGROUND

• Bredmose PP, Lockey DJ, Grier G, Watts B, Davies G. Pre-hospital use of ketamine for analgesia and procedural sedation. Emerg Med J. 2009 Jan;26(1):62-4. doi: 10.1136/emj.2007.052753.

  PMID: 19104109 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

• Herring AA, Ahern T, Stone MB, Frazee BW. Emerging applications of low-dose ketamine for pain management in the ED. Am J Emerg Med. 2013 Feb;31(2):416-9. doi: 10.1016/j.ajem.2012.08.031. Epub 2012 Nov 16. No abstract available.

  PMID: 23159425 BACKGROUND

• Jennings CA, Bobb BT, Noreika DM, Coyne PJ. Oral ketamine for sickle cell crisis pain refractory to opioids. J Pain Palliat Care Pharmacother. 2013 Jun;27(2):150-4. doi: 10.3109/15360288.2013.788599. Epub 2013 May 21.

  PMID: 23692261 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

• Johansson P, Kongstad P, Johansson A. The effect of combined treatment with morphine sulphate and low-dose ketamine in a prehospital setting. Scand J Trauma Resusc Emerg Med. 2009 Nov 27;17:61. doi: 10.1186/1757-7241-17-61.

  PMID: 19943920 BACKGROUND

• Keseg D, Cortez E, Rund D, Caterino J. The Use of Prehospital Ketamine for Control of Agitation in a Metropolitan Firefighter-based EMS System. Prehosp Emerg Care. 2015 January-March;19(1):110-115. doi: 10.3109/10903127.2014.942478. Epub 2014 Aug 25.

  PMID: 25153713 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

• Neri CM, Pestieau SR, Darbari DS. Low-dose ketamine as a potential adjuvant therapy for painful vaso-occlusive crises in sickle cell disease. Paediatr Anaesth. 2013 Aug;23(8):684-9. doi: 10.1111/pan.12172. Epub 2013 Apr 9.

  PMID: 23565738 BACKGROUND

• Richards 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: 23041484 BACKGROUND

• Uprety D, Baber A, Foy M. Ketamine infusion for sickle cell pain crisis refractory to opioids: a case report and review of literature. Ann Hematol. 2014 May;93(5):769-71. doi: 10.1007/s00277-013-1954-3. Epub 2013 Nov 15.

  PMID: 24232306 BACKGROUND

• Wiel E, Zitouni D, Assez N, Sebilleau Q, Lys S, Duval A, Mauriaucourt P, Hubert H. Continuous Infusion of Ketamine for Out-of-hospital Isolated Orthopedic Injuries Secondary to Trauma: A Randomized Controlled Trial. Prehosp Emerg Care. 2015 January-March;19(1):10-16. doi: 10.3109/10903127.2014.923076. Epub 2014 Jun 16.

  PMID: 24932670 BACKGROUND

• Yeaman F, Oakley E, Meek R, Graudins A. Sub-dissociative dose intranasal ketamine for limb injury pain in children in the emergency department: a pilot study. Emerg Med Australas. 2013 Apr;25(2):161-7. doi: 10.1111/1742-6723.12059. Epub 2013 Mar 20.

  PMID: 23560967 BACKGROUND

• Yeaman F, Meek R, Egerton-Warburton D, Rosengarten P, Graudins A. Sub-dissociative-dose intranasal ketamine for moderate to severe pain in adult emergency department patients. Emerg Med Australas. 2014 Jun;26(3):237-42. doi: 10.1111/1742-6723.12173. Epub 2014 Apr 8.

  PMID: 24712757 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Fractures, Bone

Interventions

Ketamine; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Evan Schwarz
• Organization: Washington University School of Medicine

schwarze@wustl.edu

3147473690

Study Officials

• Nicholas Musisca, MD

  Physician

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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

Study Record Dates

• First Submitted: April 25, 2015
• First Posted: April 30, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 22, 2019
• Results First Posted: May 22, 2019

Record last verified: 2019-04

Locations

US (1)