Benzydamine HCl for Postoperative Sore Throat

Phase 3

• Conditions: For Intervention
• Interventions: Drug: benzydamine HCl

• Registration Number: NCT01637883
• Lead Sponsor: Prince of Songkla University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2011-01
• Status Verified: 2012-07
• Primary Completion: 2012-07
• Study First Submitted: 2012-07-07
• Study First Submitted QC: 2012-07-07
• Study First Posted: 2012-07-11
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
benzydamine HCl	benzydamine HCl	benzydamine HCl will be dripped on the cuff of the endotracheal tube 5 minutes before induction of general anesthesia

Primary Outcome Measures

Name	Time	Method
analgesic effect	24 hours	evaluate pain score for sore throat at 0, 2, 4, 6, 12 and 24 hours after the operation

Secondary Outcome Measures

Name	Time	Method
side effects of benzydamine hydrochloride	24 hours	the incidence of throat numbness, throat burning sensation, dry mouth and thirst)within 24 hours after the operation

Trial Locations

Locations (1)

Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hatyai, Songkhla, Thailand