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Effect of preoperative tramadol gargle on postoperative throat pain in middle ear surgeries under general anaesthesia

Effect of preoperative tramadol gargle on postoperative sore throat in middle ear surgeries under general anaesthesia with endotracheal intubation - nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073464
Enrollment
62
Registered
2024-09-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: H662- Chronic atticoantral suppurative otitis media Health Condition 2: H661- Chronic tubotympanic suppurative otitis media Health Condition 3: H742- Discontinuity and dislocation of ear ossicles

Interventions

Intervention1: Effect of preoperative tramadol gargle on postoperative sore throat: Patients randomised into 2 groups by a computer generated random number table. Group A- oral tramadol(50mg tramadol

Sponsors

NEHA R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient willing to provide informed written consent ASA 1 and 2 Patients undergoing elective middle ear surgery under general anaesthesia Duration of surgery less than 4 hours

Exclusion criteria

Exclusion criteria: 1. Patients with history of preoperative sore-throat. 2. History or anticipated difficult intubation. 3. Patients requiring more than one attempt at intubation. 4. History of tramadol/opioid allergy or hypersensitivity. 5. Patients requiring the insertion of a nasogastric tube. 6. History of asthma, chronic obstructive pulmonary disease. 7. Recent upper respiratory tract infection (within 15 days). 8. Patient with history of smoking. 9. Patients on steroid therapy. 10. History of seizure disorder. 11. Patients on antidepressants.

Design outcomes

Primary

MeasureTime frame
To study the incidence and severity of sore throat up to 24 hours postoperativelyTimepoint: To study the incidence and severity at 0, 2, 6, 12, 24 hours postoperatively

Secondary

MeasureTime frame
To assess the following at 0, 2h, 6h, 12h and 24h postoperatively: - Cough - Hoarseness of voice Timepoint: 0, 2, 6, 12, 24 hours

Countries

India

Contacts

Public ContactDr G B Sumalatha

ESICMC AND PGIMSR RAJAJINAGAR BENGALURU

gbsumaravi@gmail.com9538301444

Outcome results

None listed

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