|Year : 2018 | Volume
| Issue : 1 | Page : 98-101
The role of tranexamic acid in improving quality of pediatric tonsillectomy: a double-blinded randomized controlled study
Saad D Elzayat1, Ahmed S Elgebaly2
1 Department of Otolaryngology-Head and Neck Surgery, Kaferelsheikh University, Kafr El-Sheikh, Egypt
2 Department of Anesthesia and ICU, Tanta University, Tanta, Egypt
|Date of Submission||29-May-2017|
|Date of Acceptance||22-Aug-2017|
|Date of Web Publication||14-Jun-2018|
Ahmed S Elgebaly
Department of Anesthesia and ICU, Faculty of Medicine, Tanta University, Tanta 31511
Source of Support: None, Conflict of Interest: None
This was a prospective, double-blinded, randomized controlled study.
Patients and methods
The present study included 100 patients randomized into two groups: group I included patients who did not receive tranexamic acid and group II included patients who were given tranexamic acid after induction intravenously as 15 mg/kg over 10 min.
In group I, the mean number and weight of gauze used during surgery were 5.1 + 1.30 pieces and 72 ± 6.334 ml, respectively, and in group II, they were 1.9 ± 0.35 pieces and 41 ± 8.221 ml, respectively (P < 0.001). In group I, the mean amount of blood in suction bag was 200 ± 52.36 ml, whereas it was 50 ± 10.36 ml in group II (P < 0.001). The difference between both groups regarding the number of gauze, weight, and the amount of blood in suction bag was highly significant (P < 0.001).
The present study showed that 15 mg/kg of tranexamic acid can reduce intraoperative blood loss in a highly significant manner in children undergoing tonsillectomy and in keeping stability in hemoglobin, hematocrit levels, heart rate, mean arterial blood pressure, and respiratory rate postoperatively.
Keywords: blood loss, pediatrics, tonsillectomy, tranexamic acid
|How to cite this article:|
Elzayat SD, Elgebaly AS. The role of tranexamic acid in improving quality of pediatric tonsillectomy: a double-blinded randomized controlled study. Menoufia Med J 2018;31:98-101
|How to cite this URL:|
Elzayat SD, Elgebaly AS. The role of tranexamic acid in improving quality of pediatric tonsillectomy: a double-blinded randomized controlled study. Menoufia Med J [serial online] 2018 [cited 2019 Apr 18];31:98-101. Available from: http://www.mmj.eg.net/text.asp?2018/31/1/98/234214
| Background|| |
Tonsillectomy is a common operation in both children and adults, performed by a variety of techniques . The ideal tonsillectomy has been defined as fast and bloodless and associated with rapid and uncomplicated recovery . Most patients who undergo tonsillectomy are children, so recent researches and techniques are emphasizing to make the procedure shorter in duration, with less bleeding and less pain postoperatively .
Tonsillectomy-related bleeding may occur intraoperatively or postoperatively. The postoperative bleeding is divided into primary bleeding, which occurs within 24 h of surgery, and secondary bleeding, which occurs after 24 h of surgery. Intraoperative bleeding is controlled at the time of surgery. Primary bleeding usually needs return to operating theater in 80% of cases .
Tranexamic acid is a synthetic lysine analog that inhibits the conversion of plasminogen to plasmin on the surface of the fibrin by producing an antifibrinolytic effect and reversible blockade of lysine binding sites on plasminogen molecules .
Tranexamic acid has been used in urological, cardiac, and orthopedic surgery to decrease intraoperative blood loss .
Tranexamic acid has been proven to reduce the need for blood transfusion with no increased risk of thromboembolic adverse effects .
Objectives and hypotheses of this study were to evaluate the effect of tranexamic acid on intraoperative blood loss during elective pediatric tonsillectomy and its effect on hemoglobin, hematocrit values, and postoperative vital signs.
| Patients and Methods|| |
This study was approved by the ethical committee of the Faculty of Medicine, Local ethical committee, and written informed consent was obtained from the guardian of each patient. Patients were selected from the outpatient clinic of Otorhinolaryngology Department in Dar El Shefa Hospital with insurance system collaboration. They were scheduled for elective tonsillectomy without adenoidectomy. The eligibility criteria were as follows: indication of tonsillectomy with recurrent acute tonsillitis, age range from 6 to 15 years, and with American Society of Anesthesiologists status I and II. Overall, 100 children of both sexes were enrolled in this double-blind prospective randomized study during the period from December 2015 to May 2016.
Exclusion criteria included patients with systemic diseases like liver and kidney diseases, patients with bleeding tendency like inherited coagulopathy or preoperative use of anticoagulant therapy, and those with allergies to tranexamic acid or obstructive sleep apnea with huge adenoid.
Using sealed envelopes, 100 patients were randomly allocated to two groups (50 each). Injections were prepared by an anesthesiologist who was not involved in any other aspect of the study. All syringes were identical and had similar volumes. The investigator who administered the drug, the anesthesiologist who performed the injections, and the patients were unaware of the group allocated and the drug received by the patient. After this, all measurements were made by another observer who was blinded to the patient group.
In group I, the patients did not receive tranexamic acid but received saline solution (control group). In group II, tranexamic acid was given after induction intravenously as 15 mg/kg (single bolus dose) over 10 min.
ECG and pulse oximetry were monitored. The cuff of an automated noninvasive blood pressure (BP) device was attached to the right arm. Intravenous access was prepared with a 22 G cannula in the left forearm. Induction of anesthesia was started with inhalational sevoflurane, fentanyl (l μg/kg), and rocuronium (0.6 mg/kg), and after tracheal intubation, the patients were ventilated mechanically and the anesthesia was maintained with sevoflurane (3%) and oxygen/air mixture (50%). At the end of surgery, the muscle relaxant was reversed, and the patients were extubated in a tonsillectomy position. Heart rate, noninvasive arterial BP, arterial oxygen saturation, end-tidal carbon dioxide, and body temperature were recorded every 5 min during surgery.
Bipolar cautery tonsillectomy procedures were done in accordance with the technique from the inferior to the superior and from the medial to the lateral after the medicalization of the tonsillar tissue.
Bleeding during operation was controlled by coagulation mode with bipolar cautery at 40 W.
The amount of intraoperative bleeding was also recorded by measuring the vacuum aspirator bottle where the blood accumulated and the number of bloody gauzes.
On discharge, all patients received prophylactic antibiotic therapy in the postoperative period; amoxicillin/clavulanic acid suspension 30 mg/kg three times a day for 7 days was administered orally.
The patients were given their first oral food intake – water, milk, and ice-cream – in the postoperative fourth hour.
Postoperative patient monitoring
- Vital signs such as heart rate, BP, and respiratory rate were checked after 1 h of the operation
- Calculation of blood loss: for measuring the blood in the suction jar, the fluid in the suction jar was poured into a measuring cylinder and the quantity of fluid present before the surgery was subtracted. The lower edge of the fluid meniscus after the foam had settled was considered for the readings
- Number and weight of bloody gauze. The volume of blood (ml)=(Weight of the used material − weight of material before use)/1.05
- Hemoglobin and hematocrit values compared between patients in both groups. (They were checked after 1 h of the operation.)
Sample size calculation was based on that ∼50 patients were needed in each group with a power of 0.80 and a level of significance of 5%. Qualitative data were described using number and percent. Quantitative data were described using range (minimum and maximum), mean, and SD. Comparison between different groups regarding categorical variables was tested using χ2-test. Data were fed to the computer and analyzed using IBM SPSS Statistics for Windows, version 20.0, released 2011 (IBM Corp., Armonk, New York, USA).
| Results|| |
The present study included 100 patients whose age range was from 6 to 15 years. The mean age of group I was 9.2 ± 1.62 years whereas that of group II was 8.3 ± 1.85 years. There was no significant difference between both groups according to age (P > 0.05) [Table 1].
The present study included 58 (58%) males and 52 (52%) females. In group I, 28 (56%) patients were males and 22 (44%) patients were females, whereas in group II, 30 (60%) patients were males and 20 (40%) patients were females. We did not report significant difference between both groups regarding sex distribution (P > 0.05) [Table 1].
In group I, the mean number of gauze used during surgery and weight of gauze was 5.1 + 1.30 pieces and 72 ± 6.334 ml, respectively, whereas they were 1.9 ± 0.35 pieces and 41 ± 8.221 ml, respectively, in group II. In group I, the mean amount of blood in suction bag was 200 ± 52.36 ml, whereas it was 50 ± 10.36 ml in group II. The difference between both groups regarding the number of gauze, weight of gauze, and amount of blood in suction bag was highly significant (P < 0.001) [Table 2].
The hemoglobin and hematocrit values in group I were 10.560 ± 1.400 g/dl and 27.940 ± 5.201%, respectively, whereas they were 11.620 ± 1.192 g/dl and 32.980 ± 3.490%, respectively, in group II. Vital sign measurements of the studied patients regarding heart rate, mean arterial BP, and respiratory rate were 100 ± 6.33 beats/min, 83.09 ± 10.5 mmHg, and 26.9 ± 1.99 breath/min, respectively, in group I, whereas they were 96.27 ± 6.06 beats/min, 89.59 ± 12.5 mmHg, and 22.36 ± 2.88 breath/min, respectively, in group II. There were differences between both groups regarding hemoglobin and hematocrit values, heart rate, mean arterial BP, and respiratory rate but were not significant [Table 3] and [Table 4].
|Table 3: One-hour postoperative hemoglobin and hematocrit value of the studied patients in both groups|
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|Table 4: One-hour postoperative vital signs measurements of the studied patients in both groups|
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| Discussion|| |
The present study showed highly significant effect of single intravenous dose of tranexamic acid in the cases group to decrease the incidence of bleeding and blood loss during tonsillectomy in comparison with the control group.
In a randomized controlled trial, a single dose of intravenous perioperative tranexamic acid at l0 mg/kg produced a mean blood loss of 56.61 ml in comparison with 66.52 ml in the control group during tonsillectomy using conventional dissection techniques .
An observational study done by Robb and Thorning  in pediatric patients found that tranexamic acid has potential benefits to decrease bleeding after tonsillectomy; therefore, they recommended a large, prospective, multicenter, randomized controlled trial for further investigation.
In another study done by Robb and Ewah , the use of tranexamic acid decreased the frequency and severity of postoperative bleeding following tonsillectomy, but this study was done in adult patients.
In a double-blinded control study that included 40 patients, 9–18 years of age, and randomized to either tranexamic acid (initial dose of 10 mg/kg and infusion of 1 mg/kg/h) or placebo (isotonic saline), tranexamic acid reduced significantly the total blood loss and the total amount of blood transfused in the perioperative period, but this study was done for pediatric scoliosis surgery .
Moreover, our results showed nonsignificant increase in hemoglobin, hematocrit, and mean arterial BP and decrease in heart rate and respiratory rate in group II in comparison with patients in group I, 1 h postoperatively. Our explanation for these changes is that decreasing the volume of blood loss intraoperatively was by using tranexamic acid, which gave the patients in group II these value advantages but not in group I, where the patients were affected by blood loss in a significant matter but with no harm or drawbacks on their health.
On the contrary, there are some studies against our results; two studies reported that tranexamic acid is not effective in decreasing the bleeding associated with surgery, but one study was done in hip surgery .
Another study reported no significant benefit from the routine use of tranexamic acid during tonsillectomy, but this study was done in adult patients .
A systemic review and meta-analysis of the tranexamic acid for tonsillectomy concluded that tranexamic acid did not reduce the number of patients with post-tonsillectomy hemorrhage significantly but the authors noted that these studies varied enormously in the age range, dosage, schedule, and duration of tranexamic acid administration .
In the present study, we found that the mean intraoperative blood loss was 50 ± 10.36 ml for group II, whereas it was 200 ± 52.36 ml for group I.
We have also found that the mean number of gauzes used during surgery was 5.1 + 1.30 pieces for group I, whereas it was 1.9 + 0.35 pieces in group II. Thus, the amount of intraoperative blood loss with using tranexamic acid was less in a statistically high significant manner.
The primary outcome of our study was that tranexamic acid decreases the incidence of bleeding and blood loss during pediatric tonsillectomy. Secondary outcomes were the stability of hemoglobin, hematocrit values, and postoperative vital signs.
Some limitations of this study should be noted. First, although no major complications were noticed, we used only single intravenous dose of tranexamic acid, focusing on its effects intraoperatively, and we believed that further studies are needed to evaluate its effects postoperatively. Second, the sample size was small. The study included only 100 participants who fulfilled all the inclusion criteria and had undergone elective tonsillectomy. The sample size was restricted to 100 cases because of logistical reasons. Third, the correlation between the dose of tranexamic acid, the duration of surgery, and different surgical techniques was out of the scope of our study.
| Conclusion|| |
Stability in hemoglobin levels, hematocrit values, heart rate, mean arterial BP, and respiratory rate postoperatively after intraoperative decrease in blood loss in highly significant manner can be made by the use of 15 mg/kg of tranexamic acid in pediatric patients undergoing tonsillectomy.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]