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Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children

Primary Purpose

Epistaxis, Intubation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tarivid ointment
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epistaxis

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ajou University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

ointment group

Arm Description

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

Outcomes

Primary Outcome Measures

incidence of epistaxis
percentage of the development of epistaxis after nasotracheal intubation
incidence of epistaxis
percentage of the development of epistaxis after nasotracheal intubation

Secondary Outcome Measures

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
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
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)

Full Information

First Posted
June 8, 2020
Last Updated
July 24, 2022
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04426409
Brief Title
Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children
Official Title
Effect of Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis, Intubation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Title
ointment group
Arm Type
Experimental
Arm Description
Ointment group should apply a nasal ointment to both noses using a cotton swab the night before surgery and the morning of surgery.
Intervention Type
Drug
Intervention Name(s)
tarivid ointment
Intervention Description
Vaseline ointment is applied to both noses.
Primary Outcome Measure Information:
Title
incidence of epistaxis
Description
percentage of the development of epistaxis after nasotracheal intubation
Time Frame
immediate after intubation
Title
incidence of epistaxis
Description
percentage of the development of epistaxis after nasotracheal intubation
Time Frame
immediate after extubation
Secondary Outcome Measure Information:
Title
severity of epistaxis
Description
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
Title
severity of epistaxis
Description
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
Title
Navigability
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ajou University School of Medicine
City
Suwon
State/Province
Gyeong-gi
Country
Korea, Republic of

12. IPD Sharing Statement

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Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children

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