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CompletedNCT04426409Updated Jul 26, 2022

Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children

An interventional study of tarivid ointment in Epistaxis and Intubation, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2022-07-26.

Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
4 Years to 8 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Epistaxis
  • Intubation

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03

Who can participate

Ages eligible
4 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • expected difficult intubation based on history, physical examination, weight.
  • bleeding tendency
  • upper respiratory infection within the previous 14 days
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
108 participants (actual)

Study arms

  • No intervention
    control group
  • Experimental
    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.

    Drug: tarivid ointment

Interventions

  • Drugtarivid ointment

    Vaseline ointment is applied to both noses.

05

What researchers measure

Primary outcomes

  1. incidence of epistaxis

    percentage of the development of epistaxis after nasotracheal intubation

    Time frame: immediate after intubation

  2. incidence of epistaxis

    percentage of the development of epistaxis after nasotracheal intubation

    Time frame: immediate after extubation

Secondary outcomes

  1. 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

    Time frame: immediate after intubation

  2. 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

    Time frame: immediate after extubation

  3. 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)

    Time frame: immediate after intubation

06

Study locations

1 site
  • Ajou University School of Medicine
    Suwon, Gyeong-gi, Korea, Republic of
07

Registry details

Key details

Study ID
NCT04426409
Lead sponsor
Ajou University School of Medicine
Responsible party
yun jeong chae (Professor, Ajou University School of Medicine) — Principal investigator
First posted
Jun 11, 2020
Start date
Jul 8, 2020
Primary completion
Sep 1, 2021
Completion
Sep 1, 2021
Last update
Jul 26, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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