Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children

Not Applicable

Completed

• Conditions: Intubation; Epistaxis
• Interventions: Drug: tarivid ointment

• Registration Number: NCT04426409
• Lead Sponsor: Ajou University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-11
• Study Start: 2020-07-08
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-24
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
incidence of epistaxis	immediate after extubation	percentage of the development of epistaxis after nasotracheal intubation

Secondary Outcome Measures

Name	Time	Method
Navigability	immediate after intubation	score based on easiness of navigation during intubation; 1. No resistance 2. Pass with some resistance(1try, mild) 3. Pass with some resistance (\>=2) 4. Failed to pass (Try to another nose) 5. Failed to pass both nostril (use more smaller tube)
severity of epistaxis	immediate after extubation	score based on severity of epistaxis will be recorded.; 1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx 4. severe: interfere intubation by blood

Trial Locations

Locations (1)

Ajou University School of Medicine; 🇰🇷 Suwon, Gyeong-gi, Korea, Republic of