Efficacy of Local Infiltration of Tranexamic Acid and Lidocaine in Tonsillar Bed on Postoperative Bleeding and Pain During Tonsillectomy Surgery: Prospective, Randomized, Control Study

NCT05817474 | Completed

• 1 other identifier: Mohamed
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain; Postoperative Hemorrhage

Keywords

Tonsillectomy; Lidocaine

Outcome Measures

Primary Outcomes (1)

• Postoperative bleeding, pain and postoperative opioid consumption

  Postoperative bleeding, pain and postoperative opioid consumption

  12 month

Study Arms (2)

Group T

EXPERIMENTAL

Group T: received lidocaine (2 %) 2 ml and tranexamic acid 2 ml in each tonsillar bed;

Drug: lidocaine (2 %) 2 ml and tranexamic acid

Group N

PLACEBO COMPARATOR

Group N (Control group): received 4 ml of normal saline in each tonsillar bed.

Drug: lidocaine (2 %) 2 ml and tranexamic acid

Interventions

lidocaine (2 %) 2 ml and tranexamic acid DRUG

lidocaine (2 %) 2 ml and tranexamic acid 2 ml in each tonsillar bed

Group N; Group T

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female child between 4 and 12 years old
• ASA one and two, planned for an elective tonsillectomy
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• mohamed: lead
• Al-Azhar University: collaborator

Study Sites (1)

MEDICIN

Cairo, 11765, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Hemorrhage

Interventions

Lidocaine; Tranexamic Acid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hemorrhage

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• abdalla mohamed abdalla, MD

  AZHAR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assissant professor of anesthesia

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: May 1, 2022
• Primary Completion: May 15, 2022
• Study Completion: March 1, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

EG (1)