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"THINK Trial: Treatment of Headache With IntraNasal Ketamine: A Randomized Controlled Trial Evaluating the Efficacy of Intranasal Ketamine Versus Standard Therapy in the Management of Primary Headache Syndromes in the Emergency Department" (THINK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03081416
Recruitment Status : Completed
First Posted : March 16, 2017
Last Update Posted : January 18, 2018
Information provided by (Responsible Party):
Danny Villalobos, Brooke Army Medical Center

Brief Summary:
This is a randomized, single-blind, placebo controlled trial to evaluate the efficacy of sub-dissociative dose ketamine versus standard care therapy for acute headache management of in patients presenting to the emergency department with headache as the chief compliant.

Condition or disease Intervention/treatment Phase
Headache Intranasal Ketamine Drug: Ketamine Drug: Normal saline Drug: Metoclopramide Drug: Ketorolac Drug: Dexamethasone Drug: Benadryl Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arm-Randomized placebo controlled
Masking: Single (Participant)
Masking Description: Placebo controlled
Primary Purpose: Treatment
Official Title: "THINK Trial: Treatment of Headache With IntraNasal Ketamine: A Randomized Controlled Trial Evaluating the Efficacy of Intranasal Ketamine Versus Standard Therapy in the Management of Primary Headache Syndromes in the Emergency Department"
Actual Study Start Date : May 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Intranasal Ketamine arm
Intranasal ketamine administered to participant
Drug: Ketamine
Intranasal ketamine administration

Drug: Normal saline
Other Name: Placebo

Active Comparator: Standard Therapy
Reglan 10 mg; Benadryl 25 mg administered to all participants Toradol 15-30 mg; dexamethasone 10 mg added at treating providers discretion.
Drug: Metoclopramide
Standard therapy
Other Name: Standard therapy

Drug: Ketorolac
standard therapy

Drug: Dexamethasone
Standard therapy

Drug: Benadryl
Standard therapy

Primary Outcome Measures :
  1. VAS 30 min [ Time Frame: 30 min ]
    Change in Visual Analogue Score at 30 minutes

Secondary Outcome Measures :
  1. VAS 60 min [ Time Frame: 60 min ]
    Change in Visual Analogue Score at 60 minutes

  2. NRS at discharge [ Time Frame: Discharge ]
    Numerical Rating Scale at discharge

  3. NRS 24 hours [ Time Frame: 24 hours ]
    Pain NRS score at 24 hours post discharge

  4. NRS 72 Hours [ Time Frame: 72 Hours ]
    Pain NRS score at 72 hours post discharge

  5. Side effects [ Time Frame: At 15 min then at 30 min intervals while in the ED ]
    Side effects reported by patients in both treatments arms

  6. Repeat ED/primary care encounters [ Time Frame: 24 and 72 hours ]
    Need for repeat patient evaluation at 24-72 hours

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Chief compliant of a benign, non-life threatening headache that the PI/AI believe will require parental analgesia for management.
  2. Ability to comprehend, speak, read, and write in the English language

Exclusion Criteria:

  1. Age less than 18 and greater than 65
  2. History of hypersensitivity to Ketamine, diphenhydramine, metoclopramide, ketorolac or dexamethasone
  3. Weight less than 45 kg or more than 115 kg
  4. Pregnancy or lactating female.
  5. Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis
  6. Altered mental, diminished decision making capacity
  7. Poor vital sign stability Hypoxia: O2 < 92%, Hypotension: SBP< 80 Hypertension: SBP>220 Heart rate: < 50 or >150 Respiratory Rate: <8 or >30
  8. Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis
  9. Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias
  10. History of schizophrenia, psychosis or hallucinations (as assessed by electronic chart review)
  11. History of alcohol or drug abuse
  12. History of intracranial hypertension
  13. History of glaucoma
  14. History of HIV or immunosuppression
  15. Presence of intracranial mass or vascular lesion (defined as inclusion criteria 1. As benign headaches)
  16. Poorly controlled thyroid disease
  17. Concomitant infections
  18. History of pheochromocytoma
  19. History of epilepsy
  20. History of active bleeding or those receiving anticoagulants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03081416

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United States, Texas
Brooke Army Medical Center
San Antonio, Texas, United States, 78236
Sponsors and Collaborators
Brooke Army Medical Center

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Responsible Party: Danny Villalobos, Nellis AFB Deputy Flight Commander, Brooke Army Medical Center Identifier: NCT03081416     History of Changes
Other Study ID Numbers: C.2016.072
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Headache Disorders
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents