"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"

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brooke Army Medical Center
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Diphenhydramine; Ketamine; Ketorolac; Metoclopramide; Promethazine

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.