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Ketamine v. Ketorolac for Management of Generalized Tension Type Headache

NCT03221569 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-07-06

No results posted yet for this study

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

Interventions

DRUG

Intravenous ketamine

0.3mg/kg IVPB over 15 minutes

DRUG

Ketorolac

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

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.

DRUG

Normal saline

1ml intravenous push as placebo for double-blinding purposes

Sponsors & Collaborators

  • The Brooklyn Hospital Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2020-02-01
Completion
2020-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03221569 on ClinicalTrials.gov