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ORIGINAL ARTICLE
Year : 2018  |  Volume : 31  |  Issue : 1  |  Page : 98-101

The role of tranexamicacidin improving quality of pediatric tonsillectomy: a double-blinded randomizedcontrolledstudy


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 Submission29-May-2017
Date of Acceptance22-Aug-2017
Date of Web Publication14-Jun-2018

Correspondence Address:
Ahmed S Elgebaly
Department of Anesthesia and ICU, Faculty of Medicine, Tanta University, Tanta 31511
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/mmj.mmj_377_17

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  Abstract 


Design
This was a prospective, double-blinded, randomized controlled study.
Patients and methods
The present study included 100patientsrandomized into two groups: groupI included patients who did not receive tranexamic acid and groupII included patients who were given tranexamic acid after induction intravenously as 15mg/kg over10min.
Results
In groupI, the mean number and weight of gauze used during surgery were 5.1+1.30 pieces and 72±6.334ml, respectively, and in groupII, they were 1.9±0.35 pieces and 41±8.221ml, respectively(P<0.001). In groupI, the mean amount of blood in suction bag was 200±52.36ml, whereas it was 50±10.36ml in groupII(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).
Conclusion
The present study showed that 15mg/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 tranexamicacidin improving quality of pediatric tonsillectomy: a double-blinded randomizedcontrolledstudy. Menoufia Med J 2018;31:98-101

How to cite this URL:
Elzayat SD, Elgebaly AS. The role of tranexamicacidin improving quality of pediatric tonsillectomy: a double-blinded randomizedcontrolledstudy. Menoufia Med J [serial online] 2018 [cited 2018 Aug 17];31:98-101. Available from: http://www.mmj.eg.net/text.asp?2018/31/1/98/234214




  Background Top


Tonsillectomy is a common operation in both children and adults, performed by a variety of techniques [1]. The ideal tonsillectomy has been defined as fast and bloodless and associated with rapid and uncomplicated recovery [2]. Most patients who undergo tonsillectomyarechildren, so recent researches and techniques are emphasizing to make the procedure shorter in duration, with less bleeding and less pain postoperatively [3].

Tonsillectomy-related bleeding may occur intraoperatively or postoperatively. The postoperative bleeding is divided into primary bleeding, which occurs within 24h of surgery, and secondary bleeding, which occurs after 24h of surgery. Intraoperative bleeding is controlled at the time of surgery. Primary bleeding usually needs return to operating theater in 80% of cases [4].

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 [5].

Tranexamic acid has been used in urological, cardiac, and orthopedic surgery to decrease intraoperative blood loss [6].

Tranexamic acid has been proven to reduce the need for blood transfusion with no increased risk of thromboembolic adverse effects [7].

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 Top


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 15years, 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, 100patients 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 groupI, the patients did not receive tranexamic acid but received saline solution(control group). In groupII, tranexamic acid was given after induction intravenously as 15mg/kg(single bolus dose) over10min.

Anesthetic technique

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(0.6mg/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 5min during surgery.

Surgical technique

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 30mg/kg three times a day for 7days 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

  1. Vital signs such as heart rate, BP, and respiratory rate were checked after 1h of the operation
  2. 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
  3. Number and weight of bloody gauze. The volume of blood(ml)=(Weight of the used material−weight of material before use)/1.05
  4. Hemoglobin and hematocrit values compared between patients in both groups.(They were checked after 1h of the operation.)


Statistical analysis

Sample size calculation was based on that∼50patients 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, version20.0, released 2011(IBM Corp., Armonk, NewYork, USA).


  Results Top


The present study included 100patients whose age range was from 6 to 15years. The mean age of groupI was 9.2±1.62years whereas that of groupII was 8.3±1.85years. There was no significant difference between both groups according to age (P>0.05) [Table1].
Table 1: Age and sex of the studied patients in both groups

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The present study included 58(58%) males and 52(52%) females. In groupI, 28(56%) patients were males and 22(44%) patients were females, whereas in groupII, 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) [Table1].

In groupI, the mean number of gauze used during surgery and weight of gauze was 5.1+1.30 pieces and 72±6.334ml, respectively, whereas they were 1.9±0.35 pieces and 41±8.221ml, respectively, in groupII. In groupI, the mean amount of blood in suction bag was 200±52.36ml, whereas it was 50±10.36ml in groupII. 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)[Table2].
Table 2: Intraoperative blood loss for both groups

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The hemoglobin and hematocrit values in groupI were 10.560±1.400g/dl and 27.940±5.201%, respectively, whereas they were 11.620±1.192g/dl and 32.980±3.490%, respectively, in groupII. Vital sign measurements of the studied patients regarding heart rate, mean arterial BP, and respiratory rate were 100±6.33 beats/min, 83.09±10.5mmHg, and 26.9±1.99 breath/min, respectively, in groupI, whereas they were 96.27±6.06 beats/min, 89.59±12.5mmHg, and 22.36±2.88 breath/min, respectively, in groupII. 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 Top


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 l0mg/kg produced a mean blood loss of 56.61ml in comparison with 66.52ml in the control group during tonsillectomy using conventional dissection techniques [8].

An observational study done by Robb and Thorning [9] 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 [10], 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 40patients, 9–18years of age, and randomized to either tranexamic acid(initial dose of 10mg/kg and infusion of 1mg/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 [11].

Moreover, our results showed nonsignificant increase in hemoglobin, hematocrit, and mean arterial BP and decrease in heart rate and respiratory rate in groupII in comparison with patients in groupI, 1h 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 groupII these value advantages but not in groupI, 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 [12].

Another study reported no significant benefit from the routine use of tranexamic acid during tonsillectomy, but this study was done in adult patients [13].

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 [14].

In the present study, we found that the mean intraoperative blood loss was 50±10.36ml for groupII, whereas it was 200±52.36ml for groupI.

We have also found that the mean number of gauzes used during surgery was 5.1+1.30 pieces for groupI, whereas it was 1.9+0.35 pieces in groupII. 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 100cases 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 Top


Stability in hemoglobin levels, hematocritvalues, 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 15mg/kg of tranexamic acid in pediatric patients undergoing tonsillectomy.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Pang Y. Paediatric tonsillectomy: bipolar electrodissection and dissection/snare compared. JLaryngol Otol 1995; 109:733–736.  Back to cited text no. 1
    
2.
Gurgian R, Bhusal C, Adhikari P, Pokharel R. Intraoperative blood loss & operating time in tonsillectomy: is electrodissection better? Soc Otolaryngol Nepal 2010; 1:6–7.  Back to cited text no. 2
    
3.
Nunez DA, Provan J, Crawford M. Postoperative tonsillectomy pain in pediatric patients: electrocautery(hot) vs. cold dissection and snare tonsillectomy–a randomized trial. Arch Otolaryngol Head Neck Surg 2000; 126:837–841.  Back to cited text no. 3
    
4.
Lowe D, van der Meulen J, Cromwell D, Lewsey J, Copley L, Browne J, etal. Key messages from the National Prospective Tonsillectomy Audit. Laryngoscope 2007; 117:717–724.  Back to cited text no. 4
    
5.
Wellington K, Wagstaff AJ. Tranexamic acid: a review of its use in the management of menorrhagia. Drugs 2003; 63:1417–1433.  Back to cited text no. 5
    
6.
Mahdy AM, Webster NR. Perioperative systemic haemostatic agents. Br J Anaesth 2004; 93:842–858.  Back to cited text no. 6
    
7.
Veien M, Sørensen JV, Madsen F, Juelsgaard P. Tranexamic acid given intraoperatively reduces blood loss after total knee replacement: a randomized, controlled study. Acta Anaesthesiol Scand 2002; 46:1206–1211.  Back to cited text no. 7
    
8.
Verstraete M, Tyberghein J, de Greef Y, Daems L, van Hoof A. Double-blind trials with ethamsylate, batroxobin or tranexamic acid on blood loss after adenotonsillectomy. Acta Clin Belg 1977; 32:136–141.  Back to cited text no. 8
    
9.
Robb PJ, Thorning G. Perioperative tranexamic acid in day-case paediatric tonsillectomy. Ann R Coll Surg Engl 2014; 96:127–129.  Back to cited text no. 9
    
10.
Robb PJ, Ewah B. Can tranexamic acid reduce bleeding after tonsillectomy? A pilot study. Otorinolaringologia 2013; 63:163–167.  Back to cited text no. 10
    
11.
Neilipovitz DT, Murto K, Hall L, Barrowman NJ, Splinter WM. Arandomized trial of tranexamic acid to reduce blood transfusion for scoliosis surgery. Anesth Analg 2001; 93:82–87.  Back to cited text no. 11
    
12.
Erik L, Joanne G, Christiane C. Tranexamic acid reduces the need for allogenic red blood cell transfusions in patients undergoing total hip replacement. Can J Anaesth 2004; 51:31–37.  Back to cited text no. 12
    
13.
Mazauric FX, Boudon A, Rheingold C. Value of tranexamic acid in extracapsular tonsillectomy in adults. JFr Otorhinolaryngol Audiophonol Chir Maxillofac 1973; 22:165–168.  Back to cited text no. 13
    
14.
Chan CC, Chan YY, Tanweer F. Systematic review and meta-analysis of the use of tranexamic acid in tonsillectomy. Eur Arch Otorhinolaryngol 2013; 270:735–748.  Back to cited text no. 14
    



 
 
    Tables

  [Table1], [Table2], [Table 3], [Table 4]



 

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