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

NCT04698772 | Completed

• 1 other identifier: 2019-081
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Pain

Keywords

Emergency Department; Moderate to severe pain

Outcome Measures

Primary Outcomes (1)

• Compare satisfactory scores

  The primary outcome parameter is to compare satisfaction scores between patients treated with morphine vs ketamine respectively.

  24 months

Study Arms (2)

Survey Packet 1 Group

Patients who receive "Packet 1" will be in group 1, or the treatment group. In this packet will be 4 forms: the consent to participate in the study form, a pre-treatment questionnaire (VAS and other demographic information), post-treatment questionnaire (various questions, including 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), and a form with specific instructions for the physicians to follow that vary depending on whether the instructions are from "Packet 1" or "Packet 2." The physician will be asked to administer a sub-dissociative dose of ketamine for pain control (0.3 mg/kg IV over 3-5 minutes).

Drug: Ketamine

Survey Packet 2 Group

Patients who receive "Packet 2" will be in group 2, or the control group. In this packet will be 4 forms: the consent to participate in the study form, a pre-treatment questionnaire (VAS and other demographic information), post-treatment questionnaire (various questions, including 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), and a form with specific instructions for the physicians to follow that vary depending on whether the instructions are from "Packet 1" or "Packet 2."The physician will be asked to administer morphine 4 mg IV push over 3-5 minutes for pain control.

Drug: Morphine

Interventions

Ketamine DRUG

Blinded study group will receive ketamine for pain control (0.3 mg/kg IV over 3-5 minutes)

Survey Packet 1 Group

Morphine DRUG

Blinded study group will receive morphine 4 mg IV push over 3-5 minutes for pain control

Survey Packet 2 Group

Eligibility Criteria

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

Study Population

Study subjects include patients presenting to the Emergency Department at CHRISTUS Spohn Shoreline Hospital during a 24 month time frame. Eligible patients will be treated for acute abdominal pain.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CHRISTUS Health: lead

Study Sites (1)

CHRISTUS

Corpus Christi, Texas, 78404, United States

Location

Related Publications (23)

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  BACKGROUND

• 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].

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• 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.

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

  BACKGROUND

• 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.

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• 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.

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

  BACKGROUND

• 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.

  PMID: 29760856 BACKGROUND

• 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.

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• 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.

  PMID: 28177167 BACKGROUND

• 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.

  PMID: 28285863 BACKGROUND

• 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.

  PMID: 28279542 BACKGROUND

• 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.

  PMID: 27693070 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

• 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.

  PMID: 25716117 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

• 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

• 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

• 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

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

  BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.5055/jom.2012.0096.

  PMID: 22479885 BACKGROUND

MeSH Terms

Conditions

Abdominal Pain; Emergencies

Interventions

Ketamine; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Disease Attributes; Pathologic Processes

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

Study Officials

• Rebekka Lee, DO

  CHRISTUS Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: December 19, 2019
• Primary Completion: November 16, 2020
• Study Completion: November 16, 2020
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (1)