Protocol to Ease Acute Cephalalgia in Emergency-department

Study Overview
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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.

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.

Official Title
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Therapeutic Management of Acute Cephalalgia Before and After Use of a Therapeutic Protocol in Emergency Department

Conditions
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Cephalalgia

Intervention / Treatment
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* Other: Recommendation to use global headache treatment protocol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>First arm : Passive recording head pain, linked symptoms, treatment used and diagnosis. | |
| Experimental: After protocol recommendation care<br>Recording head pain, linked symptoms, treatment used and diagnosis after intervention that is recommendation to use global headache treatment protocol | Other: Recommendation to use global headache treatment protocol<br>* The global treatment protocol is : Put the patient in a quiet spot, ideally an individual room. Avoid waiting in the corridor Lay down the patient on the stretcher. Avoid waiting on a seat or a chair. Provide a sound-proof helmet to the patient. Provide a light-blocking google to the patient. If judged necessary by the physician in charge of the patient, administer oxygen therapy, 15 liter per minute, during 15 minutes. 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | Clinical improvement is defined as Reduction of at least 50% of quantified pain 1 hour after treatment Comparison of proportion of clinical improvement between the 2 groups. | 1 hour after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score on the visual analog scale | Measure of amount of pain by recording quantified pain evaluation each 15 minutes. Analysis by ANOVA (Analysis of Variance). Comparison between the 2 groups. | 1 hour after treatment | 
| Pain depending on the kind of cephalalgia | Research of interaction between the occurrence of the clinical improvement and the cephalalgia diagnosis (Migraine, tensive headache, cluster headache, secondary headache...). | 1 hour after treatment | 
| Impact of different kind of analgesic therapeutic | Research of interaction between the occurrence of clinical improvement and the use of specific therapeutic strategy ( Restful position, calm environment, wearing opaque glasses, soundproof headset, oxygen therapy, other medication, ...) | 1 hour after treatment | 
| Length of the hospitalization in emergency department | Evaluation of the length of the hospitalization in emergency department. Comparison between the 2 groups | Duration of hospitalisation in emergency department stay, an expected average of 6 hours | 
| Time required before medication | Evaluation of the length of time before first administration of analgesic treatment. Comparison between the 2 groups | Time of administration of first medication, an expected average of 30 minutes | 
| Hospitalisation requirement | Evaluation of hospitalisation requirement at the exit of emergency department. Comparison between the 2 groups | Exit of emergency department, an expected average of 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cephalalgia, Pain, Global, Treatment, Oxygen, Emergency, Treatment of cephalalgia in emergency department, Headache, Migraine