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Prevention of postoperative sore throat

COMPARISON OF AEROSOLIZED BUDESONIDE VERSUS 5 % EMLA CREAM ON POSTOPERATIVE SORE THROAT INCIDENCE IN PATIENTS UNDERGOING ELECTIVE SURGERY: A RANDOMIZED CONTROLLED STUDY

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230907006
Enrollment
162
Registered
2023-09-07
Start date
2023-09-12
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Post operative sore throat post operative sore throat budesonide EMLA

Interventions

Patients will receive aerosolized budesonide suspension 500 microgram via nebulization 10-minutes prior to endotracheal intubation,2.5 ml (2.5 gm) of EMLA (Eutectic mixture of local anaesthetic: 2.5%
2.5% prilocaine) cream will be applied over the endotracheal tube (ETT) cuff and its distal portion prior to endotracheal intubation.,Patients will not receive any of the intervention i.e. aerosolize
Budesonide ,EMLA,Control

Sponsors

Department of Anaesthesia,Batra Hospital & Medical Research Centre, New Delhi, India
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years. 2. ASA physical status I and II. 3. Patients undergoing elective surgeries requiring endotracheal intubation

Exclusion criteria

Exclusion criteria: 1. Anticipated difficult airway. 2. Requiring more than 2 intubation attempts. 3. Known allergy to local anaesthetic drug. 4. Recent history of steroid or non-steroidal anti-inflammatory drug use 5. Systemic illness with presenting complaints of sore/dry throat (diabetics with polydipsia, hypertensives on diuretics, moribund bed ridden patients). 6. History of airway related morbidity (post operative sore throat [POST]) 7. Patients undergoing head and neck, intraoral/nasal surgery, or recent history of such surgery. 8. Surgery in prone position 9. Ongoing upper and lower respiratory tract inflammation/infection. 10. Patients requiring post operative mechanical ventilation.

Design outcomes

Primary

MeasureTime frame
Post operative sore throat (POST) At 2 hours, 6 hours, and 24 hours postoperatively Assessed using a 4-point scale: '0' no sore throat to '3' severe sore throat.

Secondary

MeasureTime frame
Post operative cough At 2 hours, 6 hours, and 24 hours postoperatively Assessed using a 4-point scale: '0' no cough to '3' severe cough. ,Post operative Hoarseness At 2 hours, 6 hours, and 24 hours postoperatively Assessed using a 4-point scale: '0' mild hoarseness to '4' severe hoarseness.,Peri-intubation haemodynamics From 5- minutes prior to induction of anaesthesia till 5-minutes post intubation of trachea heart rate (beats per minute), systolic blood pressure (mmHg), diastolic blood pressure (mmHg), and mean arterial pressure (mmHg) will be measured

Countries

India

Contacts

Public ContactMamta Sethi

Batra Hospital & Medical Research Centre

mittaldrmamta@yahoo.com00919717494499

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026