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

Primary Purpose

Post Operative Pain, Postoperative Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lidocaine (2 %) 2 ml and tranexamic acid
Sponsored by
mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Tonsillectomy, Lidocaine

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria 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. 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.

Sites / Locations

  • MEDICIN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group T

Group N

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative bleeding, pain and postoperative opioid consumption
Postoperative bleeding, pain and postoperative opioid consumption

Secondary Outcome Measures

Full Information

First Posted
April 5, 2023
Last Updated
April 19, 2023
Sponsor
mohamed
Collaborators
Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05817474
Brief Title
Efficacy of Local Infiltration of Tranexamic Acid and Lidocaine in Tonsillar Bed on Postoperative Bleeding and Pain During Tonsillectomy Surgery: Prospective, Randomized, Control Study
Official Title
Efficacy of Local Infiltration of Tranexamic Acid and Lidocaine in Tonsillar Bed on Postoperative Bleeding and Pain During Tonsillectomy Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
mohamed
Collaborators
Azhar University

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
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.
Detailed Description
The control of postoperative pain in children after tonsillectomy is a crucial issue. After a tonsillectomy, it is crucial to receive enough postoperative analgesia since discomfort limits swallowing, increases the risk of dehydration, infection, and subsequent bleeding, and can impede a quick recovery and painless convalescence. Immediately following surgery and during the first 24th hours, this pain is at its most intense (1). The main reason for reoperation and mortality in children who have had tonsillectomy is post-tonsillectomy hemorrhage (PTH). These two categories of PTH as primary bleeding in the first 24 hours and secondary bleeding (after 24th hours). Most PTH cases are secondary, with incidence reaching its peak between days 5 and 7 after surgery when the fibrin clot breaks from the tonsillar fossa. PTH requiring surgical intervention will be an emergency that most anesthesiologists will encounter in their clinical practice (2). In numerous surgical procedures, bleeding has been observed to be reduced by antifibrinolytic transexamic acid (3). It has been demonstrated that transexamic acid can reduce blood loss during tonsillectomy but has no impact on whether PTH develops in tonsillectomy patients. When administered by nebulization in the emergency room to a patient who was 3 years old, tranexamic acid has been found to reduce secondary PTH (4). Plasminogen activation is competitively inhibited by tranexamic acid. As a result of inhibition of the fibrinolysis, it prevents the clots from being broken down thereby significantly reducing surgical hemorrhage. After surgical stress, fibrinolysis occurs more frequently, especially in complex surgeries like total knee arthroplasty. Fibrinolysis reaches its peak six hours after surgery and continues to occur at a high rate for up to 18 hours. When administered during this time, tranexamic acid can significantly less blood loss (5). In those who are predisposed, thrombosis risk from tranexamic acid exists. Orthostatic difficulties, vision abnormalities, headaches, myoclonus, and rash are among other uncommon adverse effects. The safety and efficacy of tranexamic acid (TXA) have been well studied by surgical services including cardiac, orthopedic, dental, trauma, critical care, and dermatologic surgery. However, except for craniofacial surgery (6). The most serious problems following a tonsillectomy include hemorrhage and respiratory obstruction from edema. The most frequent complaint in the initial post-operative phase is pain. With individual differences, the pain increases anxiety and the fear of swallowing, predisposes to delayed food intake, reduces respiratory effort, increases the risk of pulmonary problems, and lengthens hospital stays (7). Pre-emptive analgesia, which reduces surgical pain, is the blocking of central sensitization by topical or systemic medications. Opioids, steroids, and NSAIDs have all been tested as pre-emptive analgesics, as well as local anesthetic sprays and infiltration in the tonsillar fossa (8). The use of local anesthetics, opioids, ketamine (9), gabapentin (10), corticosteroids, and even non-pharmacologic interventions as adjuvant local analgesic compounds has been cited frequently in recent years in children undergoing adenotonsillectomy (11).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Postoperative Hemorrhage
Keywords
Tonsillectomy, Lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group T
Arm Type
Experimental
Arm Description
Group T: received lidocaine (2 %) 2 ml and tranexamic acid 2 ml in each tonsillar bed;
Arm Title
Group N
Arm Type
Placebo Comparator
Arm Description
Group N (Control group): received 4 ml of normal saline in each tonsillar bed.
Intervention Type
Drug
Intervention Name(s)
lidocaine (2 %) 2 ml and tranexamic acid
Intervention Description
lidocaine (2 %) 2 ml and tranexamic acid 2 ml in each tonsillar bed
Primary Outcome Measure Information:
Title
Postoperative bleeding, pain and postoperative opioid consumption
Description
Postoperative bleeding, pain and postoperative opioid consumption
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
abdalla mohamed abdalla, MD
Organizational Affiliation
AZHAR
Official's Role
Principal Investigator
Facility Information:
Facility Name
MEDICIN
City
Cairo
ZIP/Postal Code
11765
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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