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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)

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ClinicalTrials.gov Identifier: NCT03081416
Recruitment Status : Recruiting
First Posted : March 16, 2017
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Primary Completion Date : September 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intranasal Ketamine arm
Intranasal ketamine administered to participant
Drug: Ketamine
Intranasal ketamine administration
Drug: Normal saline
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 Drug: Ketorolac Drug: Dexamethasone Drug: Benadryl


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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

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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT03081416


Contacts
Contact: Danny J Villalobos, DSc 702-653-2313 danny.j.villalobos.mil@mail.mil
Contact: Trisha Benish, Masters (210) 916-4759 trisha.m.benish.mil@mail.mil

Locations
United States, Texas
Brooke Army Medical Center Recruiting
San Antonio, Texas, United States, 78236
Contact: Trisha Benish, Masters       trisha.m.benish.mil@mail.mil   
Sponsors and Collaborators
Brooke Army Medical Center
More Information

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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Emergencies
Headache
Headache Disorders
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Dexamethasone acetate
Dexamethasone
Ketorolac
Metoclopramide
Diphenhydramine
Ketamine
BB 1101
Promethazine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents