After approval from the local ethics council (approval no. 00309/2022) and clinical trial registration (NCT05817474), eighty-two children between 4 and 12 years old of both sexes were scheduled for a tonsillectomy between March 2022 and December 2022. Informed written consent approval was obtained from the parents or the legal guardian of the child who participated in this research and randomly split into two groups:

1.

Group T: Received local infiltration of lidocaine (2%) 2 ml after induction of general anesthesia and before starting the surgery, and soaked two cotton balls with tranexamic acid 10 mg/kg (2 ml), one in each tonsillar bed at the end of surgery for 3 min and removed before extubation.

2.

Group N (control group): Two milliliters of normal saline 0.9% was locally infiltrated after general anesthesia and before starting the surgery, and soaked 2 cotton balls of normal saline (2 ml), one in each tonsillar bed at the end of the surgery for 3 min and removed before extubation.

The primary outcome was post-tonsillectomy analgesia, while secondary outcomes included post-tonsillectomy bleeding, anesthesia, operative time, paracetamol use, pain scores, and occurrence of adverse effects.

The study involved 82 children between the ages of 4 to 12 years who were randomly assigned to either the intervention group or the control group. The intervention group received lidocaine local infiltration and tranexamic acid application, while the control group received normal saline infiltration. The abstract mentions that post-tonsillectomy hemorrhage was minimized in the intervention group, and no complications were recorded following the local application of tranexamic acid and lidocaine.

Inclusion criteria

Male or female children between 4 and 12 years old, and their American Society of Anesthesiology (ASA) (I or II), were planned for an elective tonsillectomy.

Exclusion criteria

These are patients with severe obstructive sleep apnea (OSA), patient has coagulation disorders such as hemophilia, those suspected of having an allergy to the drug being administered, and those undergoing concurrent surgery such as an adenoidectomy.

Anesthetic technique

Preoperative assessment in the form of history taking, clinical examinations, and blood tests is performed preoperatively for all patients. When the patients reach the operating theater, standard monitoring is applied by a pulse oximeter, noninvasive arterial blood pressure, and electrocardiogram (ECG). Inhalational anesthesia induction with titrated sevoflurane through a face mask. After insertion of venous access, fentanyl 1 µg/kg and atracurium (0.5 mg/kg) were injected IV. The oral endotracheal tube was inserted and fixed centrally down, and then anesthesia was maintained by sevoflurane (Mac 2.5%) with mechanical ventilation and paracetamol 15 mg/kg infusion.

Forty-one children lidocaine (2%) 2 ml Infiltration in each Tonsillar bed, by (23 Gauge X 1. 1/4 inches), (Fig. 1) and 2 soaked cotton balls with tranexamic acid in each tonsillar bed at the end of the surgery (Fig. 2).

Fig. 1

During lidocaine 2% injection in tonsillar beds

Fig. 2

Examination of tonsillar bed after tonsillectomy

The other 41 children received 2 ml of normal saline infiltration in each tonsillar bed by 23 Gauge × 1.1/4 inch, and sevoflurane was discontinued and reversed muscle relaxation. Before awake extubation and transferred to the recovery room.

The Face, Legs, Activity, Cry, and Consolability (FLACC) pain score has been found reasonable interrater reliability and validity and recommended for pain assessment in children. Each of the five categories (F), (L), (A), (C), and (C) is scored from 0 to 2, which results in a total score between 0 and 10. Pain scores were categorized as mild (scores 0–3), moderate (4–6), and severe (7–10) (von Baeyer et al., 2007).

Time to the first requirement for supplemental painkillers was recorded. Paracetamol (IV) 15 mg/kg was given if the pain scores ≥ 4, and paracetamol dose (g /24 h) was recorded. Amount of tonsillectomy bleeding post-operative assessed by visual method.

Sample size calculation methods

Using a clinical sample size calculator for an intervention study; with 0.05 alpha error and power of the study 0.0.80, CI of 95%, enrolment ratio of 2. According to the literature, there was a significant difference in the need for cauterization in the operating theater between those treated with tranexamic acid and those who were not (22.2% in the group, 53.6% in the non-tranexamic group) (Spencer et al. 2022). The sample size was calculated to compare the clinical efficacy of lidocaine local infiltration and topical application of tranexamic acid in the tonsillar region during tonsillectomy operation on postoperative pain and bleeding. The least required number of patients is 74 patients including a 10% increase to cover the follow-up period (37 in each subgroup).

Method of randomizationSampling technique

A convenient sample of patients with the inclusion and exclusion criteria was sampled and enrolled in the research. Cases are to be randomly allocated into arms of the study using the concealed random allocation method until reaching total sample size calculated. Anesthetists, otorhinolaryngology surgeons, nurses, and all other researchers were unaware of each subject’s randomization.

The attendant anesthetists encoded randomly the lidocaine and tranexamic acid with the patient number and kept the clue until it matched with the results; the surgeon injected the syringe and put the cotton balls given to him by the attendant anesthetist. Post-operative, another anesthetist follows up with the patients, collects the data, and then sends it back to the attendant anesthetist. Neither the surgeon nor the follow-up anesthetist knows the clue codes or the type of medications given. The medications were labeled as number one to lidocaine and tranexamic acid and number two to saline and randomly allocated to closed envelopes with patients’ numbers.

Statistical analysis

The statistical analysis was carried out using Statistical Package for Social Sciences (SPSS) version 17 Inc. (Chicago, IL, USA). To express the data, means with standard deviations (mean ± SD) and frequencies were used. To compare both groups, a neutral T-test was applied. To check the differences for groups, the Fisher exact examination and chi-square calculation were employed. The result was deemed significant if the P was < 0.05.