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

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

Sponsors

Lead Sponsor: CHRISTUS Health

Source CHRISTUS Health
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.

Overall Status Completed
Start Date December 19, 2019
Completion Date November 16, 2020
Primary Completion Date November 16, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Compare satisfactory scores 24 months
Enrollment 32
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ketamine

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

Arm Group Label: Survey Packet 1 Group

Intervention Type: Drug

Intervention Name: Morphine

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

Arm Group Label: Survey Packet 2 Group

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Rebekka Lee, DO Principal Investigator CHRISTUS Health
Location
Facility: CHRISTUS
Location Countries

United States

Verification Date

January 2021

Responsible Party

Type: Principal Investigator

Investigator Affiliation: CHRISTUS Health

Investigator Full Name: Rebekka Lee, DO

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Survey Packet 1 Group

Description: 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).

Label: Survey Packet 2 Group

Description: 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.

Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov