Patient Satisfaction With Subdissociative Dose Ketamine Versus Morphine for Emergency Department Pain Control

Abdominal Pain Clinical Trial

Official title:

Patient Satisfaction With Subdissociative Dose Ketamine Versus Morphine for Emergency Department Pain Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04698772
• Other study ID #: 2019-081
• Status: Completed
• Start date: December 19, 2019
• Est. completion date: November 16, 2020

Study information

• Verified date: January 2021
• Source: CHRISTUS Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The proposed research will be a single blinded (patient) randomized controlled prospective trial of adult patients receiving treatment for moderate to severe abdominal pain to test the hypothesis that patient satisfaction with pain control with Ketamine will be comparable to patient satisfaction with pain control using morphine when treating abdominal pain.

Description:

Informed consent will be obtained from patients presenting with chief complaint of moderate to severe abdominal pain in the emergency department who do not meet any exclusion criteria and who willingly agree to participate by signing the written consent form. Investigators will assess the patient's opioid tolerance by asking if they have use an opioid medication in the last week, prescription opioid use at home, and/or recreational opioid use. Patients in both groups will fill out the pre-treatment questionnaire, which will include demographic questions (age, sex, race, height, weight, etc.), a 10cm (100mm) VAS for pain, a 10cm (100mm) VAS to measure patient satisfaction, and a Likert Scale to measure patient satisfaction. Post-treatment survey will be given at 30 minutes after administration of medication. The physician will record whether the patient required additional pain medication after the 30 minutes, final emergency department diagnosis, and final emergency department disposition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 16, 2020
• Est. primary completion date: November 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be at least 18 years of age
• Initial presenting complaint of moderate to severe abdominal pain (five or higher on numerical rating scale [NRS]).
• Subjects will be enrolled into the project one (1) time only.

Exclusion Criteria:

• Under 18 years of age
• Pregnant patients
• Inability to provide written consent
• Evidence of traumatic brain injury
• Hemodynamic instability
• Procedures involving laryngeal manipulation
• History of laryngeal spasm
• History of adverse reaction to Ketamine or morphine
• Patients will not be excluded if they had received pain medications prior to enrollment (ie. Received pain medication from triage, non-physician provider (NPP), or emergency medical services (EMS) prior to being seen by physician
• History of opioid use in the last week, prescription opioid use, recreational opioid use

Related Conditions & MeSH terms

• Abdominal Pain
• Emergencies

Intervention

Drug:
• Ketamine
Blinded study group will receive ketamine for pain control (0.3 mg/kg IV over 3-5 minutes)
• Morphine
Blinded study group will receive morphine 4 mg IV push over 3-5 minutes for pain control

Locations

Country	Name	City	State
United States	CHRISTUS	Corpus Christi	Texas

Sponsors (1)

Lead Sponsor	Collaborator
CHRISTUS Health

Country where clinical trial is conducted

United States, 

References & Publications (23)

"HospitalHCAHPS." CMS.gov Centers for Medicare & Medicaid Services, 21 Dec. 2017, www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/HospitalQualityInits/HospitalHCAHPS.html.

Axeen S, Seabury SA, Menchine M. Emergency Department Contribution to the Prescription Opioid Epidemic. Ann Emerg Med. 2018 Jun;71(6):659-667.e3. doi: 10.1016/j.annemergmed.2017.12.007. Epub 2018 Jan 16. — View Citation

Baker DW. The Joint Commission's Pain Standards: Origins and Evolution. Oakbrook Terrace, IL: The Joint Commission; 2017

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. — View Citation

Berkowitz B. The Patient Experience and Patient Satisfaction: Measurement of a Complex Dynamic. Online J Issues Nurs. 2016 Jan 31;21(1):1. doi: 10.3912/OJIN.Vol21No01Man01. — View Citation

Bowers KJ, McAllister KB, Ray M, Heitz C. Ketamine as an Adjunct to Opioids for Acute Pain in the Emergency Department: A Randomized Controlled Trial. Acad Emerg Med. 2017 Jun;24(6):676-685. doi: 10.1111/acem.13172. Epub 2017 Mar 22. — View Citation

Butler MM, Ancona RM, Beauchamp GA, Yamin CK, Winstanley EL, Hart KW, Ruffner AH, Ryan SW, Ryan RJ, Lindsell CJ, Lyons MS. Emergency Department Prescription Opioids as an Initial Exposure Preceding Addiction. Ann Emerg Med. 2016 Aug;68(2):202-8. doi: 10.1016/j.annemergmed.2015.11.033. Epub 2016 Feb 11. — View Citation

Francis, J. (2018). U.S. Hospitals That Provide Superior Patient Experience Generate 50 Percent Higher Financial Performance Than Average Providers, Accenture Finds. [online] Businesswire.com. Available at: https://www.businesswire.com/news/home/20160511005122/en/U.S.-HospitalsProvide-Superior-Patient-Experience-Generate [Accessed 13 Nov. 2018].

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

Karlow N, Schlaepfer CH, Stoll CRT, Doering M, Carpenter CR, Colditz GA, Motov S, Miller J, Schwarz ES. A Systematic Review and Meta-analysis of Ketamine as an Alternative to Opioids for Acute Pain in the Emergency Department. Acad Emerg Med. 2018 Oct;25(10):1086-1097. doi: 10.1111/acem.13502. Epub 2018 Jul 17. — View Citation

Linking quality to payment. Medicare.gov. https://www.medicare.gov/hospitalcompare/linking-quality-to-payment.html. Published 2018. Accessed November 21, 2018.

Morris B, Jahangir A, Sethi, M. Patient Satisfaction: An Emerging Health Policy Issue. AAOS. June 2013. http://www.aaos.org/news/aaosnow/jun13/advocacy5.asp

Motov S, Drapkin J, Likourezos A, Beals T, Monfort R, Fromm C, Marshall J. Continuous Intravenous Sub-Dissociative Dose Ketamine Infusion for Managing Pain in the Emergency Department. West J Emerg Med. 2018 May;19(3):559-566. doi: 10.5811/westjem.2017.12.36174. Epub 2018 Mar 8. — View Citation

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. — View Citation

Motov S, Rosenbaum S, Vilke GM, Nakajima Y. Is There a Role for Intravenous Subdissociative-Dose Ketamine Administered as an Adjunct to Opioids or as a Single Agent for Acute Pain Management in the Emergency Department? J Emerg Med. 2016 Dec;51(6):752-757. doi: 10.1016/j.jemermed.2016.07.087. Epub 2016 Sep 29. Review. — View Citation

Nsc.org. (2018). Prescription Drug Abuse. [online] Available at: https://www.nsc.org/home-safety/safety-topics/opioids [Accessed 13 Nov. 2018].

Patanwala AE, Edwards CJ, Stolz L, Amini R, Desai A, Stolz U. Should morphine dosing be weight based for analgesia in the emergency department? J Opioid Manag. 2012 Jan-Feb;8(1):51-5. — View Citation

Pourmand A, Mazer-Amirshahi M, Royall C, Alhawas R, Shesser R. Low dose ketamine use in the emergency department, a new direction in pain management. Am J Emerg Med. 2017 Jun;35(6):918-921. doi: 10.1016/j.ajem.2017.03.005. Epub 2017 Mar 2. Review. — View Citation

Rau J. Medicare To Begin Basing Hospital Payments On Patient-Satisfaction Scores. Kaiser Health News. https://khn.org/news/medicare-hospital-patient-satisfaction/. Published 2018. Accessed November 21, 2018.

Sin B, Tatunchak T, Paryavi M, Olivo M, Mian U, Ruiz J, Shah B, de Souza S. The Use of Ketamine for Acute Treatment of Pain: A Randomized, Double-Blind, Placebo-Controlled Trial. J Emerg Med. 2017 May;52(5):601-608. doi: 10.1016/j.jemermed.2016.12.039. Epub 2017 Mar 6. — View Citation

Sin B, Ternas T, Motov SM. The use of subdissociative-dose ketamine for acute pain in the emergency department. Acad Emerg Med. 2015 Mar;22(3):251-7. doi: 10.1111/acem.12604. Epub 2015 Feb 25. Review. — View Citation

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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare satisfactory scores	The primary outcome parameter is to compare satisfaction scores between patients treated with morphine vs ketamine respectively.	24 months