Protocol to Ease Acute Cephalalgia in Emergency-department

Cephalalgia Clinical Trial

— PEACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236442
• Other study ID #: 2014-A00973-44
• Status: Completed
• Phase: N/A
• First received: August 7, 2014
• Last updated: October 11, 2016
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertésFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cephalalgia
• Emergencies
• Headache

Intervention

Other:
• Recommendation to use global headache treatment protocol
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.

Locations

Country	Name	City	State
France	University Hospital	Grenoble	Isere

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (7)

B. D VEYSMAN, et al. Oxygen Therapy for the tratment of undifferentiated headache in the emergency department. ClinicalTrials.gov, NCT00856232

Cohen AS, Burns B, Goadsby PJ. High-flow oxygen for treatment of cluster headache: a randomized trial. JAMA. 2009 Dec 9;302(22):2451-7. doi: 10.1001/jama.2009.1855. — View Citation

Friedman BW, Grosberg BM. Diagnosis and management of the primary headache disorders in the emergency department setting. Emerg Med Clin North Am. 2009 Feb;27(1):71-87, viii. doi: 10.1016/j.emc.2008.09.005. Review. — View Citation

Haque B, Rahman KM, Hoque A, Hasan AT, Chowdhury RN, Khan SU, Alam MB, Habib M, Mohammad QD. Precipitating and relieving factors of migraine versus tension type headache. BMC Neurol. 2012 Aug 25;12:82. doi: 10.1186/1471-2377-12-82. — View Citation

Matharu M. Cluster headache. BMJ Clin Evid. 2010 Feb 9;2010. pii: 1212. Review. — View Citation

Ozkurt B, Cinar O, Cevik E, Acar AY, Arslan D, Eyi EY, Jay L, Yamanel L, Madsen T. Efficacy of high-flow oxygen therapy in all types of headache: a prospective, randomized, placebo-controlled trial. Am J Emerg Med. 2012 Nov;30(9):1760-4. doi: 10.1016/j.ajem.2012.02.010. Epub 2012 May 3. — View Citation

Rasmussen BK, Jensen R, Schroll M, Olesen J. Epidemiology of headache in a general population--a prevalence study. J Clin Epidemiol. 1991;44(11):1147-57. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No