Protocol to Ease Acute Cephalalgia in Emergency-department

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-09-30

Brief Summary

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The purpose of this study is to determine if the use of a therapeutic and global protocol to relieve cephalalgia is helpful in the emergency department of Grenoble University Hospital.

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Detailed Description

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Cephalalgia is a very common symptom that justifies daily appointment in emergency department.

Analgesic support, and especially use of oxygen and care of associated symptoms as nausea, photophobia or phonophobia, is very dependent on the physician.

The aim of this study is to evaluate the impact of a global analgesic protocol of cephalalgia in emergency department.

The investigators included 200 patients aged of 18 up to 55 years old coming in emergency department for headache. Pain (Visual analogic scale), nausea, photo or phonophobia are recorded each 15 minutes by the patient by using a self-assessment questionnaire. The final diagnosis is recorded by the physician in charge of patient, using International Headache Society criteria.

First 100 patients(group 1) receive usual care.

For the last 100 patients (group 2), physician in charge of patients are incited to use a formal protocol that include: putting the patient in a quiet spot, laying down on a stretcher, providing sound proof helmet and light blocking google, administering oxygen therapy 15 l/min during 15 min, and administering etiological headache adapted medication following learned society guidelines.

Comparison of the data of this 2 groups shall help us to see if the investigators actual analgesic support of cephalalgia is efficient, and if it can be improved by this global analgesic protocol.

Conditions

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Cephalalgia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care

First arm : Passive recording head pain, linked symptoms, treatment used and diagnosis.

Group Type NO_INTERVENTION

No interventions assigned to this group

After protocol recommendation care

Recording head pain, linked symptoms, treatment used and diagnosis after intervention that is recommendation to use global headache treatment protocol

Group Type EXPERIMENTAL

Recommendation to use global headache treatment protocol

Intervention Type OTHER

The global treatment protocol is :

1. Put the patient in a quiet spot, ideally an individual room. Avoid waiting in the corridor
2. Lay down the patient on the stretcher. Avoid waiting on a seat or a chair.
3. Provide a sound-proof helmet to the patient.
4. Provide a light-blocking google to the patient.
5. If judged necessary by the physician in charge of the patient, administer oxygen therapy, 15 liter per minute, during 15 minutes.
6. If judged necessary by the physician in charge of the patient, administer analgesic treatment adapted to the etiology of the cephalalgia as described :

Migraine : acetylsalicilyc acid + metoclopramide or nonsteroidal anti inflammatory or paracetamol or triptan.

Tension headache : nonsteroidal anti inflammatory or paracetamol. Avoid methylmorphine or tramadol if possible.

Cluster headache : Intravenous or nasal spray sumatriptan and oxygen therapy.

Other etiology : Treatment left at the discretion of the physician in charge of the patient.

Interventions

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Recommendation to use global headache treatment protocol

The global treatment protocol is :

1. Put the patient in a quiet spot, ideally an individual room. Avoid waiting in the corridor
2. Lay down the patient on the stretcher. Avoid waiting on a seat or a chair.
3. Provide a sound-proof helmet to the patient.
4. Provide a light-blocking google to the patient.
5. If judged necessary by the physician in charge of the patient, administer oxygen therapy, 15 liter per minute, during 15 minutes.
6. If judged necessary by the physician in charge of the patient, administer analgesic treatment adapted to the etiology of the cephalalgia as described :

Migraine : acetylsalicilyc acid + metoclopramide or nonsteroidal anti inflammatory or paracetamol or triptan.

Tension headache : nonsteroidal anti inflammatory or paracetamol. Avoid methylmorphine or tramadol if possible.

Cluster headache : Intravenous or nasal spray sumatriptan and oxygen therapy.

Other etiology : Treatment left at the discretion of the physician in charge of the patient.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Complain about cephalalgia
* Age 28 to 55 years.

Exclusion Criteria

* Fever \> 38,0 °C
* History of breath disease, long term use of oxygen therapy, chronic obstructive pulmonary disease, dyspnea
* History of cranial traumatism, heart attack, cerebrovascular accident \<3 month
* Inability to read or understand french.
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No