POST: Benzydamine HCl for Postoperative Sore Throat

Sponsor

Prince of Songkla University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01637883

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
For Intervention	Drug: benzydamine HCl	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Jul 1, 2012

Anticipated Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: nothing nothing will be dripped on the cuff of the endotracheal tube in the control group
Experimental: benzydamine HCl benzydamine HCl will be dripped on the cuff of the endotracheal tube 5 minutes before induction of general anesthesia	Drug: 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 Other Names: Difflam

Arm

Intervention/Treatment

No Intervention: nothing

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

Experimental: benzydamine HCl

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

Drug: 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

Other Names:

Difflam

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Prince of Songkla University	Hatyai	Songkhla	Thailand	90110

Sponsors and Collaborators

Prince of Songkla University

Investigators

Principal Investigator: Sasikaan - Nimmaanrat, MD, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110 Thailand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sasikaan Nimmaanrat, Associate Professor, Prince of Songkla University

ClinicalTrials.gov Identifier:

NCT01637883

Other Study ID Numbers:

54-039-08-1-2

First Posted:

Jul 11, 2012

Last Update Posted:

Jul 26, 2012

Last Verified:

Jul 1, 2012

Keywords provided by Sasikaan Nimmaanrat, Associate Professor, Prince of Songkla University

benzydamine HCl

endotracheal tube

postoperative sore throat

Additional relevant MeSH terms:

Pharyngitis

Benzydamine

Study Results

No Results Posted as of Jul 26, 2012