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Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04426409
Enrollment
108
Registered
2020-06-11
Start date
2020-07-08
Completion date
2021-09-01
Last updated
2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epistaxis, Intubation

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.

Interventions

DRUGtarivid ointment

Vaseline ointment is applied to both noses.

Sponsors

Ajou University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of epistaxisimmediate after intubationpercentage of the development of epistaxis after nasotracheal intubation

Secondary

MeasureTime frameDescription
severity of epistaxisimmediate after intubationscore 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
Navigabilityimmediate after intubationscore 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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026