"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"

Completed · Phase 3 · Has a placebo group

Conditions studied: Headache, Intranasal Ketamine

In brief

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.

Key facts

Study ID

NCT03081416

Run by

Brooke Army Medical Center

People needed

80

Starts

2016-05-01

Expected to finish

2017-10-01

Last updated by the study team

2018-01-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Brooke Army Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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