Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children

NCT04426409 | Completed

• 1 other identifier: AJIRB-MED-INT-19-508
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• incidence of epistaxis

  percentage of the development of epistaxis after nasotracheal intubation

  immediate after intubation

• incidence of epistaxis

  percentage of the development of epistaxis after nasotracheal intubation

  immediate after extubation

Secondary Outcomes (3)

• severity of epistaxis

  immediate after intubation

• severity of epistaxis

  immediate after extubation

• Navigability

  immediate after intubation

Study Arms (2)

control group

NO INTERVENTION

ointment group

EXPERIMENTAL

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

Drug: tarivid ointment

Interventions

tarivid ointment DRUG

Vaseline ointment is applied to both noses.

ointment group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: July 8, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

KR (1)