The use of intravenous steroids (dexamethasone)to evaulate its effectiveness on reducing the airway obstruction in children undergoing cleft palate surgery.
Phase 1
- Conditions
- Health Condition 1: Q359- Cleft palate, unspecified
- Registration Number
- CTRI/2020/05/025123
- Lead Sponsor
- Pratik Chaudhary
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Children scheduled for cleft palate repair under GA.
2.Age- 0-8 years.
3.ASA I and ASA II.
4.Children with or without obvious external anatomical variations
Exclusion Criteria
1.Patients receiving steroids pre-operatively
2.Severe cardiac or respiratory co-morbidity.
3.ASA > III.
4.Predicted difficult intubation
5.Patientâ??s denial to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of dexamethasone in preventing or reducing upper airway obstruction and lingual oedema following cleft palate repair.Timepoint: Outcome will be assessed at baseline, 6 months and 1 year of study.
- Secondary Outcome Measures
Name Time Method To compare the incidence of post-operative airway obstruction with and without prophylactic administration of intravenous dexamethasone in children undergoing cleft palate repair. <br/ ><br>A <br/ ><br>To compare the thickness of tongue post-repair between the two groups as assessed by ultrasound. <br/ ><br>Timepoint: 6 months and 1 year