Recruiting

Ketamine vs. Ketorolac

Sponsor:

The Brooklyn Hospital Center

Code:

NCT03221569

Conditions

Migraine

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Intravenous ketamine

Ketorolac

Normal saline

Normal saline

Study Details

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

Study ID

NCT03221569

Start date

Feb 1, 2016

Status verified date

Jul, 2018

Completion date

Feb 1, 2020

Anticipated

Primary completion date

Feb 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • The inclusion criteria are: Patients 18-65 years old who provides informed consent and presents to the ED with an acute tension type headache (TTH), as classified by meeting the following:

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

Exclusion Criteria: Non migraine primary headache disorder or unclassifiable, previous enrollment in study, fever >100.3, Patients with suspected secondary headache disorder such as SAH or sinusitis, performance of lumbar puncture or potential need for LP, Severe hypertension (≥180/100), History of CAD or hypertension, presence of/suspected for traumatic head injury in the past 30 days with or without loss of consciousness, Presence of/suspected for myocardial ischemia, presence of/suspected for alcohol intoxication, Hemodynamic instability, history of psychiatric disorders, known or suspected pregnancy or breast feeding, allergy to ketamine, ketorolac, previous enrollment in the study, patients with language barriers, refusal to provide consent to receive intravenous therapy, reported illicit drug use within the past 5 days, patients weighing over 100kg

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

active comparator: ketorolac

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

Interventions

Intravenous ketamine

0.3mg/kg IVPB over 15 minutes

Ketorolac

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

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.

Normal saline

1ml intravenous push as placebo for double-blinding purposes

Primary outcome measure

  • Pain scores [ Time Frame: At 30 minutes after initiation of study intervention ]

Central Contacts and Locations

Central contacts

Billy Sin, PharmD

718-250-5000bsin@tbh.org

Locations

The Brooklyn Hospital Center

Recruiting

Brooklyn, New York, United States, 11201

Contacts

Billy W Sin, Pharm.D.

718-250-6250

More Information

Sponsor

The Brooklyn Hospital Center

Last update posted

Jul 6, 2018

Last verified

Jul, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Brooklyn Hospital Center on 2018-07-06.