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Benzydamine HCl for Postoperative Sore Throat

NCT ID: NCT01637883

Last Updated: 2012-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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For Intervention

Keywords

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benzydamine HCl endotracheal tube postoperative sore throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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nothing

nothing will be dripped on the cuff of the endotracheal tube in the control group

Group Type NO_INTERVENTION

No interventions assigned to this group

benzydamine HCl

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

Group Type EXPERIMENTAL

benzydamine HCl

Intervention Type DRUG

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

Interventions

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benzydamine 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

Intervention Type DRUG

Other Intervention Names

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Difflam

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Sasikaan Nimmaanrat

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sasikaan - Nimmaanrat, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110 Thailand

Locations

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Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status RECRUITING

Countries

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Thailand

Facility Contacts

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Sasikaan - Nimmaanrat, MD

Role: primary

Kadesirin - Chokkijchai

Role: backup

Other Identifiers

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54-039-08-1-2

Identifier Type: -

Identifier Source: org_study_id