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NCT Number: NCT04426409

Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children

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.

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Key information

Conditions

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

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tarivid ointment

Drug

Vaseline ointment is applied to both noses.

Primary outcomes

  1. incidence of epistaxis

    Time frame: immediate after intubation

    percentage of the development of epistaxis after nasotracheal intubation

  2. incidence of epistaxis

    Time frame: immediate after extubation

    percentage of the development of epistaxis after nasotracheal intubation

Secondary outcomes

  1. severity of epistaxis

    Time frame: immediate after intubation

    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

  2. severity of epistaxis

    Time frame: 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

  3. Navigability

    Time frame: immediate after intubation

    score based on easiness of navigation during intubation

    • 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)

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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