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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03056352
Other study ID # 2017-7511
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date March 1, 2017
Est. completion date August 15, 2017

Study information

Verified date July 2018
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date August 15, 2017
Est. primary completion date July 20, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Traumatic injury to the head has occurred

- Headache has developed within 7 days of injury to the head

- Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache)

- The headache must be rated as moderate or severe in intensity at the time of initial evaluation.

- The plan of the attending emergency physician must include treatment with parenteral metoclopramide.

Exclusion Criteria:

- Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of monoamine oxidase inhibitors, and use of anti-rejection transplant medications. Patients will not be excluded for pregnancy or breast-feeding.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metoclopramide
Intravenous medication drip
Diphenhydramine
Intravenous medication drip

Locations

Country Name City State
United States Montefiore Medical Center Bronx New York

Sponsors (1)

Lead Sponsor Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Sustained Headache Relief Sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration. 2 hours thru 48 hours after treatment
Secondary Post Concussion Symptoms Assessed by Post-concussive Symptom Scale The post-concussive symptom scale is a questionnaire administered verbally. The post-concussive symptom ranges from 0 to 132. 0= no post-concussive symptoms. 132= severe post-concussive symptoms. 7 days
Secondary Number of Participants Satisfied With Medication; Assessed by Self-evaluation Satisfaction is measured by a positive response to the question "Would you want to receive the same medication during a subsequent visit for post-traumatic headache?" 48 hours after treatment
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