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

January 5, 2021 updated by: Rebekka Lee, DO, CHRISTUS Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • CHRISTUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Blinded study group will receive ketamine for pain control (0.3 mg/kg IV over 3-5 minutes)
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
Blinded study group will receive morphine 4 mg IV push over 3-5 minutes for pain control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare satisfactory scores
Time Frame: 24 months
The primary outcome parameter is to compare satisfaction scores between patients treated with morphine vs ketamine respectively.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHRISTUS Health

Investigators

  • Principal Investigator: Rebekka Lee, DO, CHRISTUS Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2019

Primary Completion (Actual)

November 16, 2020

Study Completion (Actual)

November 16, 2020

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Actual)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigator has interest in pursuing future collaboration and grant opportunities.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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