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

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ClinicalTrials.gov Identifier: NCT04698772
Recruitment Status : Completed
First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Rebekka Lee, DO, CHRISTUS Health

Tracking Information
First Submitted Date January 5, 2021
First Posted Date January 7, 2021
Last Update Posted Date January 7, 2021
Actual Study Start Date December 19, 2019
Actual Primary Completion Date November 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 5, 2021)
Compare satisfactory scores [ Time Frame: 24 months ]
The primary outcome parameter is to compare satisfaction scores between patients treated with morphine vs ketamine respectively.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patient Satisfaction With Subdissociative Dose Ketamine Versus Morphine for Emergency Department Pain Control
Official Title Patient Satisfaction With Subdissociative Dose Ketamine Versus Morphine for Emergency Department Pain Control
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Abdominal Pain
Intervention
  • Drug: Ketamine
    Blinded study group will receive ketamine for pain control (0.3 mg/kg IV over 3-5 minutes)
  • Drug: Morphine
    Blinded study group will receive morphine 4 mg IV push over 3-5 minutes for pain control
Study Groups/Cohorts
  • 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: 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.
    Intervention: Drug: Morphine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 5, 2021)
32
Original Actual Enrollment Same as current
Actual Study Completion Date November 16, 2020
Actual Primary Completion Date November 16, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04698772
Other Study ID Numbers 2019-081
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: The investigator has interest in pursuing future collaboration and grant opportunities.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Rebekka Lee, DO, CHRISTUS Health
Study Sponsor CHRISTUS Health
Collaborators Not Provided
Investigators
Principal Investigator: Rebekka Lee, DO CHRISTUS Health
PRS Account CHRISTUS Health
Verification Date January 2021