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OpenTrials
Completed

NCT Number: NCT01011673

Metoclopramide Versus Ketorolac for Tension-type Headache

Occasionally, episodic tension-type headache may be severe enough to require an emergency department (ED) visit. The purpose of this study is to compare two commonly used medications to see which is better for tension type headache. Patients who present to the ED with an acute tension-type headache requiring treatment with injectable medication will be randomized to metoclopramide or ketorolac.

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Key information

Conditions

Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tension-Type Headache

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute tension type headache

Exclusion criteria

  • Contraindications to investigational medications
  • Secondary cause of headache

Treatment and study plan

Metoclopramide

Drug

metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS

Other names: Reglan

Ketorolac

Drug

ketorolac 30mg IVSS

Other names: Toradol

Primary outcomes

  1. Change in Pain Score

    Time frame: Baseline, 60 minutes

    At baseline at at 60 minutes, all patients were asked to describe their pain on a scale from 0 to 10, with 0 representing no pain and 10 the worst imaginable. The primary outcome is the 60 minute score subtracted from the baseline score

Secondary outcomes

  1. Satisfaction Scores

    Time frame: 24 hours

    24 hours after the emergency department visit, patients were asked, "The next time you come to the Er with this type of headache, do you want to receive the same medication?" Affirmative answers are tabulated here.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

An RCT of Metoclopramide/Diphenhydramine vs. Ketorolac Alone for Tension-type Headache

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 11, 2009
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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