Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Intubation Complication

Treatments: Drug: Benzydamine Hydrochloride; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03074968

H1612-061-813

Details and patient eligibility

About

This study is designed to examine the effect of benzydamine hydrochloride to postoperative sore throat in pediatric patients. We will spray benzydmaine hydrochloride or normal saline at oral cavity and the tip of endotracheal tube, than compare the prevalence of postoperative sore throat using smartphone application in pediatric patients.

Full description

1. postoperative sore throat incidence (over 2) 1; no, 2;mild, 3;moderate, 4;severe
2. scoring of pain with smartphone application (kids pain scale)
3. incidence of use of rescue pain killer

Enrollment: 142 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• general anesthesia
• intubation require

Exclusion criteria

• recent upper airway infection
• could not express the pain

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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142 participants in 2 patient groups, including a placebo group

control

Placebo Comparator group

Description:

normal saline

Treatment:

Drug: Normal saline

benzydamine hydrochloride

Active Comparator group

Description:

Benzydamine Hydrochloride

Treatment:

Drug: Benzydamine Hydrochloride