SLCTR Registration Number
Date of Registration
The date of last modification
Jun 29, 2017
Scientific Title of Trial
Effectiveness of para nasalsinus air suction in the treatment of acute migraine headache - A randomized, double-blind, placebo-controlled Study
Public Title of Trial
Nasal air suction in the treatment of acute migraine headache
Disease of Health Condition(s) Studied
Effectiveness of para nasalsinus air suction in the treatment of acute migraine headache
Universal Trial Number
Any other number(s) assigned to the trial and issuing authority
38/2016 (ERC:Medical Research Institute, Sri Lanka)
What is the research question being addressed?
What is the efficacy of paranasal sinus air suction compared to a placebo device in the treatment of acute migraine in school children aged 16-19 years?
Type of study
Randomized controlled trial
The study will be carried out among school children in the Kandy District.
Participant allocation will be through stratified block randomization. A total of 12 schools will be selected using simple randomization. Participants in each school will be allocated into the intervention and control arms using block randomization (block size=4).
The intervention arm will receive nasal air suction for a period of 60 seconds with 10 seconds interval to each nostril. This will be delivered by a Compact High Suction Unit SUC81500 (capacity minimum of 32 liters of free air per minutes and suction,720 mmHg against a barometer of 760mmHg).
The control arm will receive placement of an identical placebo device without air suction a period of 60 seconds with 10 seconds interval to each nostril. The appearance of the nasal air mask and the sound of air suction will be indistinguishable from the active device.
The participants will be given standard treatment for migraine with their usual rescue pain medication and anti-emetics following application of the device. Additional medical therapy for acute migraine attacks (e.g. sumatriptan, aspirin, ibuprofen, paracetamol and domperidone) will be made available with qualified medical officers at the intervention site.
Participants and outcome assessors will be blinded to the intervention.
Male and female school children
Age 16-19 years
Diagnosed with migraine according to the IHS-criteria ICHD-II 1.1: Migraine without aura [G43.0] 1.2: Migraine with aura [G43.1]
Complaint of a single migraine headache of moderate or severe intensity
History of cranial lesion or tumor
Recent nasal or sinus infective illness, trauma and runny nose
Known to abuse alcohol or drugs
Females on hormonal therapy for any condition or illness
Diagnosed psychiatric illness
Any other acute or chronic illness
Participants on non-medical/non-nutritional treatment for migraine prevention such as acupuncture or psychotherapy.
Participants on current medical treatment for acute migraine or migraine prophylaxis
Non-provision of informed consent and/or having lack of understanding of the information regarding the study
Headache relief (defined as reduction of headache pain intensity from severe or moderate migraine headache to mild or none) at 60 seconds post-application of the device.
Change in severity of suborbital tenderness/ scalp tenderness due to migraine headache
The above will be measured using a 10 point pain scale and a 4 point Glaxo visual analogue scale.
Primary outcome(s) - Time of assessment(s)
Secondary outcome(s) - Time of assessment(s)
Target number/sample size
46 (23 in each arm)
Countries of recruitment
Anticipated start date
Anticipated end date
State of ethics review approval
Approved by the Research Committee of the Medical Research Institute on 10th January 2017 (Ref. 38/2016)
None (Investigator funded)
Contact person for Scientific Queries/Principal Investigator
Dr. S.M. Rathnasiri Bandara
Neurology Unit, Teaching Hospital Kandy, Kandy, Sri Lanka
Contact Person for Public Queries
Dr. D.M.P.U.K. Ralapanawa
Consultant Physician and Senior Lecturer
Department of Medicine Faculty of Medicine, University of Peradeniya Sri Lanka