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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01406860
Other study ID # 201008798
Secondary ID University of Io
Status Terminated
Phase N/A
First received September 22, 2010
Last updated November 27, 2017
Start date July 2011
Est. completion date July 2012

Study information

Verified date November 2017
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if droperidol is equally as effective as metoclopramide for treatment of primary headaches in the Emergency Department.


Recruitment information / eligibility

Status Terminated
Enrollment 19
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- 18 years old to 65 years old, diagnosis of primary headache

Exclusion Criteria:

- Allergy to study medications, pregnant, breast-feeding, prisoners, non-english speaking, not eligible to receive droperidol based on ED protocol (see below), patients in whom head trauma, infection, vascular disorders, and disorders of facial or cranial structures are suspected

ED Droperidol Protocol

Droperidol must NOT be used in patients with any of the following:

- Known or suspected QT prolongation, including congenital long QT syndrome

- Cardiac Disease [cardiomyopathy, congestive heart failure, hypertension, ischemic heart disease, myocardial infarction, bradycardia (< 50 bpm)]

- History of the following:

- Renal failure

- Cerebrovascular disease

- Diabetes or hypoglycemia

- Alcoholism/alcohol abuse

- Pituitary insufficiency

- Hypothyroidism

- Hypothermia

- Anorexia

- Advanced age (>65 yrs)

- Use of the following medications: digoxin, benzodiazepine, diuretics, IV opiates, or other medications known to prolong the QTc interval.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Droperidol
Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
Metoclopramide + diphenhydramine
Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.

Locations

Country Name City State
United States University of Iowa Hospitals and Clinics Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Scale (Numerical Rating Scale for Pain) Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)
Secondary Length of Stay Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes)
Secondary 24 Hour Pain Score 24 hour pain score (follow-up phone call) 24 hours after discharge from ED
Secondary Adverse Effects Frequency of adverse effects in each arm From the time when the treatment is initiated until the 24 hour follow-up phone survey