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Protocol to Ease Acute Cephalalgia in Emergency-department

Not Applicable
Completed
Conditions
Cephalalgia
Interventions
Other: Recommendation to use global headache treatment protocol
Registration Number
NCT02236442
Lead Sponsor
University Hospital, Grenoble
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
After protocol recommendation careRecommendation to use global headache treatment protocolRecording head pain, linked symptoms, treatment used and diagnosis after intervention that is recommendation to use global headache treatment protocol
Primary Outcome Measures
NameTimeMethod
Clinical improvement1 hour after treatment

"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.

Secondary Outcome Measures
NameTimeMethod
Length of the hospitalization in emergency departmentDuration of hospitalisation in emergency department stay, an expected average of 6 hours

Evaluation of the length of the hospitalization in emergency department. Comparison between the 2 groups

Pain score on the visual analog scale1 hour after treatment

Measure of amount of pain by recording quantified pain evaluation each 15 minutes. Analysis by ANOVA (Analysis of Variance).

Comparison between the 2 groups.

Time required before medicationTime of administration of first medication, an expected average of 30 minutes

Evaluation of the length of time before first administration of analgesic treatment.

Comparison between the 2 groups

Pain depending on the kind of cephalalgia1 hour after treatment

Research of interaction between the occurrence of the "clinical improvement" and the cephalalgia diagnosis (Migraine, tensive headache, cluster headache, secondary headache...).

Impact of different kind of analgesic therapeutic1 hour after treatment

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, ...)

Hospitalisation requirementExit of emergency department, an expected average of 6 hours

Evaluation of hospitalisation requirement at the exit of emergency department.

Comparison between the 2 groups

Trial Locations

Locations (1)

University Hospital

🇫🇷

Grenoble, Isere, France

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