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Clinical Trials/NCT04698772
NCT04698772CompletedNot Applicable

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

CHRISTUS Health1 site in 1 country32 target enrollmentStarted: December 19, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
1
Primary Endpoint
Compare satisfactory scores

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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).

Intervention: Ketamine (Drug)

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.

Intervention: Morphine (Drug)

Outcomes

Primary Outcomes

Compare satisfactory scores

Time Frame: 24 months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rebekka Lee, DO

Principal Investigator

CHRISTUS Health

Study Sites (1)

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