Ketamine v. Ketorolac for Management of Generalized Tension Type Headache

NCT03221569 | Unknown Phase 4 FDA Drug

• 1 other identifier: 779354-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of the study is that sub-dissociative dose ketamine will prove to be superior to or as standard therapy, ketorolac, in the treatment of acute tension type headache (TTH) as measured by the 10 point Numerical Rating Scale (NRS. The aim of the study is to compare the safety \& efficacy of intravenous sub-dissociative dose ketamine versus ketorolac for acute treatment of migraines in the Emergency Department (ED) The primary endpoints are: Patient perception of pain as described by the use the Numerical Rating Scale (NRS) at 30 minutes. The secondary endpoints are: Frequency and mean dose of rescue/additional doses of therapy at 15, 30, 45, 60, 75, 90 min, Number of emergency department re-visits for acute migraine one month post discharge, incidence of dissociative effects (characterized by hallucination, disorientation, confusion, agitation, delirium, dreams) during study period, incidence of nausea, vomiting, or worsening headache, Incidence of bad taste, Incidence of burning sensations in the nostrils, incidence of hypertension, time to patient discharge from the initiation of study medication/placebo, patient satisfaction of pain control based on a Likert Scale.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Pain scores

  10 point number rating scale

  At 30 minutes after initiation of study intervention

Secondary Outcomes (3)

• Incidence of adverse events

  throughout study period (105 mins)

• mean dose of rescue analgesia required

  throughout study period (105 minutess)

• length of stay

  throughout study period (105 minutes)

Study Arms (2)

Intravenous ketamine

EXPERIMENTAL

Arm will include 0.3 mg/kg intravenous piggyback ketamine over 10 minutes for 1 dose and a 1ml normal saline placebo via intravenous push

Drug: Intravenous ketamine; Drug: Normal saline

ketorolac

ACTIVE COMPARATOR

Arm will include 30mg ketorolac intravenous push and 50ml normal saline over 10 minutes

Drug: Ketorolac; Drug: Normal saline

Interventions

Intravenous ketamine DRUG

0.3mg/kg IVPB over 15 minutes

Also known as: ketamine intravenous

Intravenous ketamine

Ketorolac DRUG

as active comparator, will be administered together with metoclopramide in one normal saline 50ml bag

ketorolac

Normal saline DRUG

Will be given as 50ml intravenous bag as placebo for double-blinding purposes in patients who will also receive intranasal ketamine. Will be prepared in intranasal syringe for double blinding purposes for patients who are randomized to receive intranasal ketamine.

Also known as: saline

Intravenous ketamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have at least 10 episodes of headache occurring on average less than 12 days per year AND Fullfuling B-D B. Lasting 30mins to 7 days C. At least 2 of the following 4 criteria
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• bilateral location
• pressing/tightening (non-pulsating)
• mild or moderate
• not aggravated by routine physical activity such as walking or climbing stairs D. Both of the following
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• no nausea/vomiting
• No more than one of photophobia or phonophobia

Sponsors & Collaborators

• The Brooklyn Hospital Center: lead

Study Sites (1)

The Brooklyn Hospital Center

Brooklyn, New York, 11201, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

Ketorolac; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Billy Sin, PharmD

CONTACT

718-250-5000; bsin@tbh.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Aside from primary investigator (B.Sin) and pharmacist procuring the study interventions, blinding will be applied to patient, physicians, nurses, research associates responsible for collect data and also the independent biostatistician responsible for evaluating the data. Patients will be randomized to receive study numbers that corresponds to treatment arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Emergency Medicine Clinical Research Program

Model Details: Arm A would include 0.3mg/kg intravenous piggyback ketamine and 1cc normal saline as placebo via intravenous push while Arm B would receive 50ml normal saline and ketorolac 30mg.

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 18, 2017
• Study Start: February 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: July 6, 2018

Record last verified: 2018-07

Locations

US (1)