CompletedPhase 3ketamine

"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"

Sponsored by Brooke Army Medical Center

NCT ID
NCT03081416
Target Enrollment
80 participants
Start Date
2016-05
Est. Completion
2017-10

About This Study

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.

Conditions Studied

HeadacheIntranasal Ketamine

Interventions

  • Ketamine
  • Normal saline
  • Metoclopramide
  • Ketorolac
  • Dexamethasone
  • Benadryl

Eligibility

Age:18 Years - 65 Years
Healthy Volunteers:Yes
View full eligibility 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.

Study Locations (1)

Brooke Army Medical Center
San Antonio, Texas, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source