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

C

CHRISTUS Health

Status

Completed

Conditions

Abdominal Pain

Treatments

Drug: Ketamine
Drug: Morphine

Study type

Observational

Funder types

Other

Identifiers

NCT04698772
2019-081

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

32 participants in 2 patient groups

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).
Treatment:
Drug: Ketamine
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.
Treatment:
Drug: Morphine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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