Clinical TrialHeadache Disorders (Cluster & Migraine)PlaceboKetaminePlaceboTerminated

The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine (Check)

Randomised, triple-blind, parallel Phase III ED trial (n=5) comparing IV ketamine 0.3 mg/kg + ondansetron 4 mg to prochlorperazine 10 mg + diphenhydramine 25 mg for benign headache; terminated.

Target Enrollment
5 participants
Study Type
Phase III interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, triple-blind, parallel design conducted in the emergency department comparing standard prochlorperazine (10 mg IV) plus diphenhydramine (25 mg IV) versus ketamine 0.3 mg/kg IV with ondansetron 4 mg IV. Participants received a single intravenous treatment and were observed with repeated assessments up to 60 minutes.

Outcomes collected at 15, 30, 45 and 60 minutes included heart rate, blood pressure, and 100-mm VAS measures of headache, nausea, vomiting, anxiety and restlessness; a 24–48 hour follow-up assessed pain and satisfaction with migraine pain management.

Study Protocol

Preparation

sessions

Dosing

1 sessions
60 min each

Integration

sessions

Study Arms & Interventions

Standard treatment

active comparator

Prochlorperazine 10 mg IV + diphenhydramine 25 mg IV (standard ED care).

Interventions

  • Placebo
    via IV• single dose

    Prochlorperazine 10 mg IV + diphenhydramine 25 mg IV (standard treatment).

Ketamine

experimental

Ketamine 0.3 mg/kg IV + ondansetron 4 mg IV (research arm).

Interventions

  • Ketamine0.3 mg/kg
    via IV• single dose
  • Placebo
    via IV• single dose

    Ondansetron 4 mg IV given with ketamine.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.
  • Inclusion Criteria
  • Age 18 to 65 years who present to the ED with complaint of a headache
  • Temperature less than 100.4 F
  • Diastolic blood pressure less than 104 mm Hg
  • Normal neurologic exam and normal mental status

Exclusion Criteria

  • Exclusion Criteria
  • Pregnant or breastfeeding
  • Meningeal signs are present
  • Acute angle closure glaucoma is suspected
  • Head trauma within the previous two weeks
  • Lumbar puncture within the previous two weeks
  • Thunderclap (rapid) onset of the headache
  • Weight more than 150 kg or less than 40 kg
  • Known allergy to diphenhydramine
  • Known allergy to ondansetron (Zofran)
  • Known allergy to Compazine
  • Known allergy to Ketamine
  • History of schizophrenia or bipolar disorder
  • History of intracranial hypertension
  • Is a prisoner
  • Patient declined informed consent
  • Non-English speaking patient
  • Attending provider excludes patient
  • Elderly patients with dementia
  • Patients with severe headaches that diminish their decision making capability will not be able to participate

Study Details

Study Team

Sponsors & Collaborators

Locations

Mike O'Callaghan Federal Medical Center — Nellis Air Force Base, Nevada, United States

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