Clinical trial NCT02236442: Protocol to Ease Acute Cephalalgia in Emergency-department
Official title: Therapeutic Management of Acute Cephalalgia Before and After Use of a Therapeutic Protocol in Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cephalalgia
Keywords: Cephalalgia
Headache
Migraine
Pain
Global
Treatment
Oxygen
Emergency
Treatment of cephalalgia in emergency department
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical improvement
timeFrame: 1 hour after treatment
Secondary outcomes:
measure: Pain score on the visual analog scale
timeFrame: 1 hour after treatment
measure: Pain depending on the kind of cephalalgia
timeFrame: 1 hour after treatment
measure: Impact of different kind of analgesic therapeutic
timeFrame: 1 hour after treatment
measure: Length of the hospitalization in emergency department
timeFrame: Duration of hospitalisation in emergency department stay, an expected average of 6 hours
measure: Time required before medication
timeFrame: Time of administration of first medication, an expected average of 30 minutes
measure: Hospitalisation requirement
timeFrame: Exit of emergency department, an expected average of 6 hours
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
state: Isere
Study officials:
affiliation: University Hospital, Grenoble
name: Gabriel Mirebeau, Resident
role: PRINCIPAL_INVESTIGATOR
References:
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citation: B. D VEYSMAN, et al. Oxygen Therapy for the tratment of undifferentiated headache in the emergency department. ClinicalTrials.gov, NCT00856232