Benzydamine HCl for Postoperative Sore Throat

Efficacy of Benzydamine Hydrochloride Dripping at Endotracheal Tube Cuff for Prevention of Postoperative Sore Throat

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01637883

Acronym

POST

Enrollment

Registered

2012-07-11

Start date

2011-01-31

Completion date

2012-08-31

Last updated

2012-07-26

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

Conditions

For Intervention

Keywords

benzydamine HCl, endotracheal tube, postoperative sore throat

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.

Interventions

DRUGbenzydamine HCl

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026