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Clinical trial

A Comparison Between Local Anesthetics and Topical Cortikosteroids That is Applied to the Area of Cuff of Tracheal Intubation Tube in Pediatric Patients

ID
Name
AOLC-1
Description
This study aims to compare effects of two different agents on complications due to tracheal tube cuff in pediatric patients. Sore throat, hoarseness, laryngospasm, bronchospasm are the main complications.
Trial arms
Trial start
2019-11-01
Estimated PCD
2020-06-15
Trial end
2020-06-15
Status
Completed
Treatment
Lidocaine 10% Spray
lidocaine will be apply on the cuff
Arms:
lidocaine group
Other names:
lidocaine
Mometasone nasal spray
mometasone spray will be applied on the cuff
Arms:
steroid group
Other names:
steroid
Size
91
Primary endpoint
Visual analog scale (VAS) for pain
1 hour
Visual analog scale (VAS) for pain
6 hours
Visual analog scale (VAS) for pain
12 hours
Visual analog scale (VAS) for pain
24 hours
Eligibility criteria
Inclusion Criteria: * Being ages between 2 and 18 * undergoing elective surgery * intubated patients over 1 hour * ASA(American Society of Anesthesiologists) Class I-II patients Exclusion Criteria: * Urgent surgeries * Tonsillectomies, adenoidectomies ..etc, operations that causes sore throat due to the operation area.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 91, 'type': 'ACTUAL'}}
Updated at
2023-11-18

1 organization

2 products

3 indications

Organization
Derince Training and Research Hospital
Product
Lidocaine
Indication
Anesthesia Intubation Complication
Indication
Complications of Intubation
Indication
Sore Throat
Product
Mometasone