"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"

NCT03081416 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: C.2016.072
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache; Intranasal Ketamine

Outcome Measures

Primary Outcomes (1)

• VAS 30 min

  Change in Visual Analogue Score at 30 minutes

  30 min

Secondary Outcomes (6)

• VAS 60 min

  60 min

• NRS at discharge

  Discharge

• NRS 24 hours

  24 hours

• NRS 72 Hours

  72 Hours

• Side effects

  At 15 min then at 30 min intervals while in the ED

Study Arms (2)

Intranasal Ketamine arm

EXPERIMENTAL

Intranasal ketamine administered to participant

Drug: Ketamine; Drug: Normal saline

Standard Therapy

ACTIVE COMPARATOR

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

Interventions

Ketamine DRUG

Intranasal ketamine administration

Intranasal Ketamine arm

Normal saline DRUG

Also known as: Placebo

Intranasal Ketamine arm

Metoclopramide DRUG

Standard therapy

Also known as: Standard therapy

Standard Therapy

Ketorolac DRUG

standard therapy

Standard Therapy

Dexamethasone DRUG

Standard therapy

Standard Therapy

Benadryl DRUG

Standard therapy

Standard Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• Poorly controlled thyroid disease

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78236, United States

Location

MeSH Terms

Conditions

Headache

Interventions

Ketamine; Saline Solution; Metoclopramide; Standard of Care; Ketorolac; Dexamethasone; Diphenhydramine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Phenyl Ethers; Phenols; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Ethylamines; Amines; Benzhydryl Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nellis AFB Deputy Flight Commander

Model Details: Two arm-Randomized placebo controlled

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 16, 2017
• Study Start: May 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2017
• Last Updated: January 18, 2018

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)