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Register:	ISRCTN
Last refreshed on:	21 February 2022
Main ID:	ISRCTN13783111
Date of registration:	08/01/2018
Prospective Registration:	No
Primary sponsor:	University Medical Center, King Abdullah Medical City
Public title:	Blocking of the Sphenopalatine ganglion (nerve cells located behind the nose) is an effective treatment for acute migraine headaches
Scientific title:	Sphenopalatine ganglion block for the treatment of acute migraine headache
Date of first enrolment:	01/03/2017
Target sample size:	55
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN13783111
Study type:	Observational
Study design:	Open uncontrolled retrospective study (Treatment)
Phase:	Not Specified

Countries of recruitment
Bahrain

Contacts

Name:	Mohamed Albinfalah
Address:	University Medical Center, King Abdullah Medical City PO Box 26671 109 Manama Bahrain
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged between 18 to 60 years of age
2. Diagnosed with migraine headache (according to International Classification of Headache Disorders-3 Beta since at least one year)
3. Present with moderate to severe headache not responding to abortive medications

Exclusion criteria:
1. Patients with medication overuse headache
2. Bleeding disorders
3. Abnormal neurological examination
4. History of allergy to local anesthetics

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Acute migraine headache
Nervous System Diseases
Acute migraine headache

Intervention(s)

Prior to procedure, the nose is inspected for any obstruction, and xylometazoline 0.05% nasal drops (one drop in each nostril) are used to help open the nasal passages. Face temperature is recorded using temperature sensor skin probes put on both cheeks. A small amount of 2% lidocaine jelly is installed in each nostril for patients’ comfort, using a needless syringe. Each patient received a single treatment of transnasal SPG block with 2 cc of 2% lidocaine in each nostril in the supine position with head extension, delivered using the Sphenocath® device. This is a small flexible sheath with a curved tip. It is inserted through the anterior nasal passage parallel to nasal septum and above the middle turbinate. Once in place, the inner catheter is advanced to administer 2cc of 2% lidocaine. It is then removed and the procedure is repeated on the other side. Typically after the block, there is an increase in face temperature by 1 to 2 degrees Celsius and/or tearing. The patient is instructed to remain in the same position for 10 minutes. Pain is assessed using numeric rating scale (NRS), where 0 is no pain and 10 is worst pain imaginable; this was recorded at baseline, 15 minutes, 2 hours and 24 hours after the procedure. We also recorded patient global impression of change (PGIC; very poor, poor, no change, good, very good) at 2 hours and 24 hours post-procedure.

Primary Outcome(s)

1. Percentage of patients free of headache using the numeric rating scale at 15 minutes, 2 hours and 24 hours
2. Pain is assessed using the numeric rating scale (NRS) at baseline, 15 minutes, 2 hours and 24 hours after the procedure

Secondary Outcome(s)

1. Headache relief rate, defined as percentage of patients with 50% or more reduction in headache intensity is measured using the numeric rating scale (NRS) at 15 minutes, 2 hours and 24 hours (using the NRS)
2. Change in NRS from baseline to 15 minutes, 2 hours and 24 hours post-treatment
3. Patient global impression of change (on a scale: very poor, poor, no change, good, very good), measuring effects on headache and its associated symptoms, and tolerability) at 2 hours and 24 hours
4. All adverse events reported by the patients up to 24 hours post-procedure

Secondary ID(s)

70809

Source(s) of Monetary Support

University Medical Center, King Abdullah Medical City

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Institutional Review Board of University Medical Center at King Abdullah Medical City, 20/02/2017

Results

Results available:	Yes
Date Posted:
Date Completed:	31/10/2017
URL:

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