Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children

Intubation Clinical Trial

Official title:

Effect of Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426409
• Other study ID #: AJIRB-MED-INT-19-508
• Status: Completed
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: July 2022
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Epistaxis
• Intubation

Intervention

Drug:
• tarivid ointment
Vaseline ointment is applied to both noses.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University School of Medicine	Suwon	Gyeong-gi

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of epistaxis	percentage of the development of epistaxis after nasotracheal intubation	immediate after intubation
Primary	incidence of epistaxis	percentage of the development of epistaxis after nasotracheal intubation	immediate after extubation
Secondary	severity of epistaxis	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	immediate after intubation
Secondary	severity of epistaxis	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	immediate after extubation
Secondary	Navigability	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)	immediate after intubation