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OpenTrials
Completed

NCT Number: NCT04698772

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRISTUS

Corpus Christi, Texas, 78404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

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

Morphine

Drug

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

Primary outcomes

  1. Compare satisfactory scores

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

CHRISTUS Health

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 7, 2021
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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