Ketamine v. Ketorolac for Management of Generalized Tension Type Headache

NCT ID: NCT03221569

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2020-02-01

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.

Detailed Description

This will be a "double-dummy" study in that there will be no placebo only arm. Medications will be administered in a double blind randomized fashion. Patients would be enrolled in Arm A or Arm B depending upon the initial randomization. Arm A would include 0.3 mg/kg ketamine into a 100 cc normal saline IV bag and normal saline injection (1ml) while Arm B would receive 100cc of normal saline and 30mg of ketorolac intravenously.

An order would be placed by the medical resident, medical attending, a study investigator who is a physician, or a pharmacist under the permission of the attending physician into Allscripts for a study intervention. Upon receiving the order in Allscripts, the order would be verified by the pharmacy. All medications will be prepared in pharmacy, which will maintain a master list of contents of each sealed envelope. Once notified of which envelope has been pulled, the pharmacist will prepare either arm. ED personnel will obtain the infusion preparation from pharmacy. It will be labeled for the patient, with study number, but without other identifying marks. When the study medication is picked up, pharmacy will open the sealed envelope to confirm which medication arm was prepared in order to internally verify the correct preparation. The nurse assigned to the patient would administer the intervention. A research associate or a study investigator would approach the patient to assess and record primary outcomes, secondary outcomes at designed time intervals. The data will be recorded on the data collection instrument. If additional medication is requested by the patient, the orders would be placed by the medical resident or attending who are assigned to the patient in the ED. Upon completion of the treatment portion of the study, patients will be asked of the participant's satisfaction with therapy. Only the patient who signed the consent form will be allowed to answer the questions.

All data retrieved from the paper data collection sheets will be transcribed into an encrypted and password protected electronic database by the research associate. All patient identifiers would be de-identified in the database. All participants would be assigned a study participant number.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intravenous ketamine

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

Group Type: EXPERIMENTAL

Intravenous ketamine

Intervention Type: DRUG

0.3mg/kg IVPB over 15 minutes

Normal saline

Intervention Type: 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.

ketorolac

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

Group Type: ACTIVE_COMPARATOR

Ketorolac

Intervention Type: DRUG

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

Normal saline

Intervention Type: DRUG

1ml intravenous push as placebo for double-blinding purposes

Interventions

Intravenous ketamine

0.3mg/kg IVPB over 15 minutes

Intervention Type: DRUG

Ketorolac

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

Intervention Type: DRUG

Normal saline

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.

Intervention Type: DRUG

Normal saline

1ml intravenous push as placebo for double-blinding purposes

Intervention Type: DRUG

Other Intervention Names

ketamine intravenous; saline; saline

Eligibility Criteria

Inclusion Criteria

1. 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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1. bilateral location

2. pressing/tightening (non-pulsating)

3. mild or moderate

4. not aggravated by routine physical activity such as walking or climbing stairs D. Both of the following

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1. no nausea/vomiting

2. No more than one of photophobia or phonophobia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Brooklyn Hospital Center

OTHER

Sponsor Role: lead

Responsible Party

Billy Sin

Director, Emergency Medicine Clinical Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Brooklyn Hospital Center

Brooklyn, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Billy Sin, PharmD

Role: CONTACT

bsin@tbh.org

718-250-5000 ext. 2450

Facility Contacts

Billy W Sin, Pharm.D.

Role: primary

718-250-6250

Other Identifiers

779354-2

Identifier Type: -

Identifier Source: org_study_id