The CHECK Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine

The Check Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine. A Multi-Center, Randomized Double-Blind, Clinical Control Trial.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02657031

Enrollment

Registered

2016-01-15

Start date

2016-03-17

Completion date

2017-03-21

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache

Keywords

Headache, Migraine

Brief summary

This study compares the efficacy of low dose Ketamine versus Compazine for the control of headache in patients presenting to the Emergency Department.

Detailed description

After enrollment, each patient will randomized either to the standard treatment arm to receive prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV, OR to the study arm to receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. The diphenhydramine or ondansetron will be administered first, and immediately afterward the prochlorperazine or Ketamine will be administered. The prochlorperazine or Ketamine will be diluted in saline so that the total volume is 5 mL, and will be administered over 2 minutes. The diphenhydramine will be diluted in saline so that it is 2 mL (the same volume as the ondansetron). Both groups will also receive a 500 mL normal saline bolus after the study medications are administered. The ED pharmacist will be responsible for preparing the medications, using a double-blind protocol. He or she will record which arm the patient was randomized to. Only the pharmacist will have access to the randomization records and will not reveal the randomization until the end of the study. Emergency providers will be instructed not to administer any rescue medications for at least 30 minutes. The electronic medical record order will read randomized study medication (for the Ketamine or prochlorperazine) and randomized add-on medication (for the ondansetron or diphenhydramine).

Interventions

DRUGProchlorperazine

prochlorperazine 10 mg IV

DRUGKetamine

Ketamine 0.3 mg/kg IV

DRUGDiphenhydramine

Diphenhydromine 25 mg IV

DRUGOndansetron

Ondansetron 4 mg IV

DRUGNormal Saline

Normal Saline 500 cc IV Bolus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Intervention model description

Double-Blind Randomized Clinical Control Trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age 18 to 65 years * Temperature \< 100.4° F * Diastolic Blood Pressure \<104 mm Hg * Normal neurological exam and mormal mental status

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 onset of the headache * Weight more than 150 kg or less than 40 kg. * Known allergy to one of the study drugs. * 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

Design outcomes

Primary

Measure	Time frame	Description
Headache Following Intervention	0-60 minutes	Reduction in 100 mm Visual Analog Scale (VAS) Score. Positive values represent a reduction in headache severity. The maximum possible change in VAS score is 100 mm, representing the complete relief of a maximally severe headache. A change of 0 mm corresponds to no change in headache severity, and a negative value indicates worsening of the headache after the medication.

Secondary

Measure	Time frame	Description
Anxiety	0-60 minutes	Reduction in 100 mm Visual Analog Scale (VAS) Score. The maximum possible change in VAS score is 100 mm, representing the complete relief of maximum anxiety. A change of 0 mm corresponds to no change in anxiety level, and a negative value indicates worsening of the anxiety after the medication.
Nausea	0-60 minutes	Reduction in 100 mm Visual Analog Scale (VAS) Score. The maximum possible change in VAS score is 100 mm, representing the complete relief of maximum nausea. A change of 0 mm corresponds to no change in nausea level, and a negative value indicates worsening of the nausea after the medication.
The Number of Participants Experiencing Vomiting	0-60 minutes	Yes/No
The Number of Patients Experiencing Restlessness	0-60 minutes	Yes/No

Countries

United States

Participant flow

Participants by arm

Arm	Count
Control Arm This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus Prochlorperazine: prochlorperazine 10 mg IV Diphenhydromine: Diphenhydromine 25 mg IV Normal Saline: Normal Saline 500 cc IV Bolus	28
Study Arm This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Sailing 500 cc bolus. Ketamine: Ketamine 0.3 mg/kg IV Ondansetron: Ondansetron 4 mg IV Normal Saline: Normal Saline 500 cc IV Bolus	23
Total	51

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	2

Baseline characteristics

Characteristic	Total	Control Arm	Study Arm
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	51 Participants	28 Participants	23 Participants
Age, Continuous	34.9 years STANDARD_DEVIATION 10.3	37.4 years STANDARD_DEVIATION 10.4	32.3 years STANDARD_DEVIATION 10.3
Race/Ethnicity, Customized Caucasian	16 participants	9 participants	7 participants
Region of Enrollment United States	51 participants	28 participants	23 participants
Sex: Female, Male Female	39 Participants	20 Participants	19 Participants
Sex: Female, Male Male	12 Participants	8 Participants	4 Participants
Visual Analog Scale (VAS) Pain Score, mm	78 mm STANDARD_DEVIATION 17	78.3 mm STANDARD_DEVIATION 17.7	77.8 mm STANDARD_DEVIATION 14.6

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 29	0 / 25
other Total, other adverse events	1 / 29	2 / 25
serious Total, serious adverse events	0 / 29	0 / 25

Arm	Measure	Value (NUMBER)
Control Arm	The Number of Patients Experiencing Restlessness	3 participants
Study Arm	The Number of Patients Experiencing Restlessness	3 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026