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Post Operative PainNCT05817474

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

A study testing lidocaine (2 %) 2 ml and tranexamic acid in people with Post Operative Pain and Postoperative Hemorrhage, run by mohamed at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 12 years
Conditions the study is for
Post Operative Pain, Postoperative Hemorrhage
What is being tested?
lidocaine (2 %) 2 ml and tranexamic acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
1 siteEgypt
Study dates
1 May 2022to 1 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • MEDICIN

    Cairo, 11765

Other trials in Egypt

About this study

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

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.

Read the 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).

Being tested
lidocaine (2 %) 2 ml and tranexamic acid
Keywords
Tonsillectomy, Lidocaine
Medical subject headings
Pain, Postoperative, Postoperative Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lidocaine (2 %) 2 ml and tranexamic acidDrug

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

Study groups in NCT05817474
Study groupRoleWhat they receive
Group TExperimentalGroup T: received lidocaine (2 %) 2 ml and tranexamic acid 2 ml in each tonsillar bed;
Receives: Drug: lidocaine (2 %) 2 ml and tranexamic acid
Group NPlacebo comparatorGroup N (Control group): received 4 ml of normal saline in each tonsillar bed.
Receives: Drug: lidocaine (2 %) 2 ml and tranexamic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative bleeding, pain and postoperative opioid consumption

    Postoperative bleeding, pain and postoperative opioid consumption

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start1 May 2022
  3. Primary completion15 May 2022
  4. Study completion1 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05817474
Sponsor's protocol ID
Mohamed
Status last verified
Apr 2023
First submitted
5 Apr 2023
Last updated
21 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing lidocaine (2 %) 2 ml and tranexamic acid in people with Post Operative Pain and Postoperative Hemorrhage, run by mohamed at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative bleeding, pain and postoperative opioid consumption (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.

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