Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children

NCT ID: NCT04426409

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-08
• Study Completion Date: 2021-09-01

Brief Summary

Nasotracheal intubation is one of the anesthetic procedures required for oral surgery. It allows the surgeon easier access to the surgical site than the orthotracheal intubation. Therefore, nosotracheal intubation is commonly used for general anesthesia for oral and maxillofacial surgery and dental treatment. However, nasotracheal intubation can damage the nasal mucosa in the course of the tube passing through the nostrils, causing epistaxis which is reported as the most common side effect.

In order to reduce these side effects, heating of the tube and use of a tube lubricant immediately before intubation have been recommended in children. However, research on whether the dry state of the mucosa itself contributes to the development of epistaxis is limited. A study in adults reported that pretreatment of the ointment on the mucosa reduced the damage to the mucosa. However, its effect on the incidence of epistaxis in children has not been studied.

The purpose of this study is to investigate the effects of pretreatment of nasal ointment on epistaxis of nasotracheal intubation in children.

Conditions

Epistaxis; Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

ointment group

Ointment group should apply a nasal ointment to both noses using a cotton swab the night before surgery and the morning of surgery.

Group Type: EXPERIMENTAL

tarivid ointment

Intervention Type: DRUG

Vaseline ointment is applied to both noses.

Interventions

tarivid ointment

Vaseline ointment is applied to both noses.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists physical statue I or II
• Patients scheduled to undergo surgery under nasotracheal intubation

Exclusion Criteria

• expected difficult intubation based on history, physical examination, weight.
• bleeding tendency
• upper respiratory infection within the previous 14 days

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

yun jeong chae

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

AJIRB-MED-INT-19-508

Identifier Type: -

Identifier Source: org_study_id