Preoperative Use of Montelukast Sodium
The Effects on Airway Reactivity of the Use of Preoperative Montelukast Sodium
1 other identifier
interventional
30
1 country
1
Brief Summary
Supraglottic airway equipment used during anaesthesia application can lead to airway reactivity or even larynx spasm in sensitive children. Montelukast Sodium, used in asthma treatment, is a cysteinyl leukotriene Type 1 antagonist which reduces leukotriene C4, leukotriene D4 and leukotriene E4 synthesis. The use of Montelukast Sodium in airway reactivity is known to reduce the need for bronchodilator and corticosteroids.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 10, 2015
CompletedJuly 10, 2015
July 1, 2015
1.1 years
May 5, 2015
July 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants with bronchospasm as a Measure of airway reactivity
during the operation
Number of Participants with laryngospasm as a Measure of airway reactivity
during the operation
Number of Participants with apnea
during the operation
Secondary Outcomes (2)
amount of applied steroids
during the operation
peak airway pressures as a measurement of airway reactivity
during the operation
Study Arms (3)
Group E (n=10)
ACTIVE COMPARATORPatients with high Ig E levels
Group C (n=10)
ACTIVE COMPARATORPatients with normal Ig E levels
Group M (n=10)
ACTIVE COMPARATORPatients who would be administered with 4mg PO MS 10 days before surgery because of high IgE
Interventions
4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.
Eligibility Criteria
You may qualify if:
- Patients undergoing inguinal hernia surgery
You may not qualify if:
- If receiving asthma treatment,
- If they had URTI in the last week and
- If LMA could not be placed at a single attempt.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gulsah Karaoren
Istanbul, Turkey (Türkiye)
Related Publications (2)
Casares-Alonso I, Cano-Garcinuno A, Blanco-Quiros A, Perez-Garcia I. Anti-asthmatic prescription variability in children according to age. Allergol Immunopathol (Madr). 2015 Jul-Aug;43(4):383-91. doi: 10.1016/j.aller.2014.05.010. Epub 2014 Oct 23.
PMID: 25444114BACKGROUNDBush A. Montelukast in paediatric asthma: where we are now and what still needs to be done? Paediatr Respir Rev. 2015 Mar;16(2):97-100. doi: 10.1016/j.prrv.2014.10.007. Epub 2014 Dec 12.
PMID: 25499571RESULT
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Nurten Bakan, MD
Unraniye training and research hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 5, 2015
First Posted
July 10, 2015
Study Start
May 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 10, 2015
Record last verified: 2015-07