The use of intravenous steroids (dexamethasone)to evaulate its effectiveness on reducing the airway obstruction in children undergoing cleft palate surgery.

Efficacy of Intravenous Dexamethasone to Reduce Postoperative Upper Airway Obstruction and Tongue Edema in Children Undergoing Palatoplasty-A Prospective, Randomized, Double-Blind Trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025123

Enrollment

100

Registered

2020-05-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q359- Cleft palate, unspecified

Interventions

Intervention1: Dexamethasone: The dexamethasone- 0.25 mg/kg and the placebo- normal saline- will be prepared in 2 ml syringes and labeled as â??Drugâ?? to ensure administration in double blind fashion

the attending anesthesiologist and the observer who records tongue thickness/ upper airway obstruction will not be aware of the content of the syringe. Control Intervention1: Placebo (Normal Saline):

the attending anesthesiologist and the observer who records tongue thickness/ upper airway obstruction will not be aware of the content of the syringe.

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To compare the incidence of post-operative airway obstruction with and without prophylactic administration of intravenous dexamethasone in children undergoing cleft palate repair. A To compare the thickness of tongue post-repair between the two groups as assessed by ultrasound. Timepoint: 6 months and 1 year	—

Countries

India

Contacts

Public ContactPreethy J Mathew

PGIMER,Chandigarh

drpratikchaudhary@gmail.com8158062624

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026