N/A
N=73
, "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
Epistaxis
Bottom Line
View on ClinicalTrials.gov: NCT02517294 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Number of Participants With Epistaxis — 11; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Parker flex-tip nasotracheal tube (Device); Standard nasotracheal tube (Device)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Epistaxis |
11; 2 | — |
| SECONDARY Number of Participants With Nasotracheal Tube Impingement |
6; 3 | — |
| SECONDARY Number of Participants With Postoperative Epistaxis |
1; 0 | — |
| SECONDARY Number of Participants With Postoperative Croup |
0; 1 | — |
| SECONDARY Time to Discharge in Minutes |
32.1; 30.4 | — |
Summary
Comparison is made between standard nasotracheal tubes and a specially designed nasotracheal tube during nasotracheal intubation in children undergoing general anesthesia for dental surgery.
Eligibility Criteria
Inclusion Criteria
- children between the ages of 3-11, ASA 1-3, presenting to Wolfson Children's Hospital (WCH) for dental procedures requiring general anesthesia with nasotracheal intubation.
Exclusion Criteria
- ASA >3
- known bleeding disorders
- recent or ongoing treatment with blood-thinning medicines
- frequent epistaxis
- active URI/congestion/rhinorrhea
- craniofacial abnormalities prohibiting NTI
- known difficult airway
- prior nasal surgery/trauma
- allergies to any of the medicines used in this study.
Data sourced from ClinicalTrials.gov (NCT02517294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.