Clinical trial

Efficacy of Local Infiltration of Tranexamic Acid and Lidocaine in Tonsillar Bed on Postoperative Bleeding and Pain During Tonsillectomy Surgery.

Name
Mohamed
Description
All anesthetic techniques aim to lessen intra-operative surgical site bleeding because it is a major problem and does not help with precision, surgery time, or postoperative wound healing. The main reason for reoperation and mortality in children who have had tonsillectomies is post-tonsillectomy hemorrhage. Pre-emptive analgesia reduces surgical pain blocking of central sensitization by topical or systemic medications.
Trial arms
Trial start
2022-05-01
Estimated PCD
2022-05-15
Trial end
2023-03-01
Status
Completed
Treatment
lidocaine (2 %) 2 ml and tranexamic acid
lidocaine (2 %) 2 ml and tranexamic acid 2 ml in each tonsillar bed
Arms:
Group N, Group T
Size
94
Primary endpoint
Postoperative bleeding, pain and postoperative opioid consumption
12 month
Eligibility criteria
Inclusion criteria 1. Male or female child between 4 and 12 years old 2. ASA one and two, planned for an elective tonsillectomy 3. Patients having 4 or more episodes of tonsillitis in the last year, 5 or more episodes in the previous two years, or 7 episodes in the previous three years. Exclusion criteria 1-Children with diabetes mellitus, problems of the heart, kidneys, or liver 4-Obstructive sleep apnea syndrome 5-blood disorders, or a propensity to hemorrhage 6-patients suspected of an allergy to the drug being administered, and those undergoing concurrent surgery such as an adenoidectomy or tongue tie.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 94, 'type': 'ACTUAL'}}
Updated at
2023-04-21

1 organization

1 product

2 indications

Organization
Mohamed
Product
Lidocaine