Benzydamine HCl for Postoperative Sore Throat

Prince of Songkla University86 enrolled

Overview

To evaluate the analgesic effect of benzydamine hydrochloride dripping on the endotracheal tube cuff for postoperative sore throat.

The investigators will assign patients into either the benzydamine hydrochloride or the control group. The whole ETT cuff will be either dripped with 3 ml (4.5 mg) of benzydamine hydrochloride or nothing 5 minutes prior to anesthesia induction. The incidence and severity of POST at 0, 2, 4, 6, 12 and 24 hours postoperatively will be assessed. The potential adverse effects of benzydamine hydrochloride (throat numbness, throat burning sensation, dry mouth and thirst) will also be evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

For Intervention

Interventions

benzydamine HClDRUG

3 ml (4.5 mg) of benzydamine hydrochloride will be dripped on the cuff of the endotracheal tube 5 minutes prior to induction of general anesthesia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 18-65 years * ASA status I-II * Mallampati grade I-II * Duration of surgery less than 4 hours * Patients placed in the supine position Exclusion Criteria: * Undergoing oral, cervical spine or thyroid surgery * More than one attempt of ETT intubation or intubated with a technique of rapid sequence induction with cricoid pressure * Insertion of nasogastric/orogastric tube or esophageal stethoscope * Complaint of sore throat or hoarseness * Presence of upper respiratory tract infection within 7 days prior to the operation * Gastroesophageal reflux * Known allergy to benzydamine hydrochloride or other nonsteroidal anti-inflammatory drugs (NSAIDs)

Locations (1)

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

RECRUITING

Outcomes

Primary Outcomes

analgesic effect

evaluate pain score for sore throat at 0, 2, 4, 6, 12 and 24 hours after the operation

Time frame: 24 hours

Secondary Outcomes

side effects of benzydamine hydrochloride

the incidence of throat numbness, throat burning sensation, dry mouth and thirst)within 24 hours after the operation

Time frame: 24 hours

Data from ClinicalTrials.gov

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