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Completed

NCT Number: NCT02236442

Protocol to Ease Acute Cephalalgia in Emergency-department

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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Key information

Conditions

Cephalalgia Brain Diseases Central Nervous System Diseases Disease Attributes Emergencies Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Grenoble, Isere, 38700, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recommendation to use global headache treatment protocol

Other

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.

Primary outcomes

  1. Clinical improvement

    Time frame: 1 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 outcomes

  1. Pain score on the visual analog scale

    Time frame: 1 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.

  2. Pain depending on the kind of cephalalgia

    Time frame: 1 hour after treatment

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

  3. Impact of different kind of analgesic therapeutic

    Time frame: 1 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, ...)

  4. Length of the hospitalization in emergency department

    Time frame: Duration 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

  5. Time required before medication

    Time frame: Time 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

  6. Hospitalisation requirement

    Time frame: Exit of emergency department, an expected average of 6 hours

    Evaluation of hospitalisation requirement at the exit of emergency department.

    Comparison between the 2 groups

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: PEACE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 10, 2014
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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