NCT01637883

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

July 26, 2012

Status Verified

July 1, 2012

Enrollment Period

1.5 years

First QC Date

July 7, 2012

Last Update Submit

July 25, 2012

Conditions

For Intervention

Keywords

benzydamine HClendotracheal tubepostoperative sore throat

Outcome Measures

Primary Outcomes (1)

  • analgesic effect

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

    24 hours

Secondary Outcomes (1)

  • side effects of benzydamine hydrochloride

    24 hours

Study Arms (2)

nothing

NO INTERVENTION

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

benzydamine HCl

EXPERIMENTAL

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

Drug: benzydamine HCl

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

Also known as: Difflam
benzydamine HCl

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

MeSH Terms

Interventions

Benzydamine

Intervention Hierarchy (Ancestors)

IndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Sasikaan - Nimmaanrat, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 7, 2012

First Posted

July 11, 2012

Study Start

January 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

July 26, 2012

Record last verified: 2012-07

Locations

TH(1)