Saudi Journal of Anaesthesia

ORIGINAL ARTICLE
Year
: 2013  |  Volume : 7  |  Issue : 3  |  Page : 229--233

Effects of tranexamic acid during endoscopic sinsus surgery in children


Ahmed A Eldaba1, Yasser Mohamed Amr1, Osama A Albirmawy2,  
1 Department of Anesthesia and Surgical Intensive Care, Tanta University, Tanta, Egypt
2 Department of ENT, Tanta University Hospital, Tanta University, Tanta, Egypt

Correspondence Address:
Yasser Mohamed Amr
Department of Anesthesia,Tanta University Hospital, Tanta University, Tanta 31257
Egypt

Abstract

Objectives: This study was conducted to evaluate the effect of tranexamic acid (TA) on the intra-operative bleeding during the functional endoscopic sinus surgery (FESS) in children. Methods: A total of 100 children recruited to undergo FESS were randomized into two groups. Group I: Was given just after induction, intra-venous 25 mg/kg TA diluted in 10 ml of normal saline. Group II: Was given 10 ml of normal saline. Non-invasive blood pressure, heart rate, and quality of the surgical field were estimated every 15 min. Volume of bleeding and duration of the surgical procedure were recorded. Results: Surgical field quality after 15 min revealed that seven patients in group I had minimal bleeding versus no one in group II, P=0.006. Meanwhile, 35 patients in group I had mild bleeding versus 26 patients in group II, P=0.064. Higher number of patients in group II than in group I had moderate bleeding, P=0006. Also, at 30 min, revealed that 10 patients in group I had minimal bleeding versus one patient in group II, P=0.004. Meanwhile, 37 patients in group I had mild bleeding versus 28 patients in group II, P=0.059. Higher number of patients in group II than in group I had moderate bleeding, P<0001. Duration of the surgeries and volume of bleeding were significantly less in tranexamic group than the placebo group, P<0.0001. Conclusion: Single intra-venous bolus dose of tranexamic in children during the FESS improves quality of surgical field, reduces intra-operative bleeding, and duration of surgery.



How to cite this article:
Eldaba AA, Amr YM, Albirmawy OA. Effects of tranexamic acid during endoscopic sinsus surgery in children.Saudi J Anaesth 2013;7:229-233


How to cite this URL:
Eldaba AA, Amr YM, Albirmawy OA. Effects of tranexamic acid during endoscopic sinsus surgery in children. Saudi J Anaesth [serial online] 2013 [cited 2020 Apr 6 ];7:229-233
Available from: http://www.saudija.org/text.asp?2013/7/3/229/115314


Full Text

 Introduction



Treatment of chronic sinusitis using the functional endoscopic sinus surgery (FESS) has become popular among otolaryngologists. [1]

The procedure became an accepted treatment for children. [2] It must be carried out under general anesthesia. Several published series of children undergoing FESS have described positive outcomes ranging from 80% to 100%. [3],[4] The most common complication during the FESS is bleeding, which sometimes prevents the surgeon from completing the procedure. [5],[6],[7]

Tranexamic acid (TA) is a synthetic derivative of the amino acid lysine that exerts its antifibrinolytic effect through the reversible blockade of lysine binding sites on plasminogen molecules and thereby inhibiting the interaction of plasminogen and the heavy chain of plasmin with lysine residues on the surface of fibrin. Suppression of fibrinolysis by TA is manifested by reduction in blood levels of D-Dimer. However, the drug has no effect on blood coagulation parameters. [8],[9]

This study was conducted to evaluate the effect of TA on the intra-operative bleeding during FESS in children.

 Methods



A total of 100 children suffering from the chronic rhinosinusitis and aged between 5 years and 10 years were recruited to undergo FESS, these patients' first time candidates for sinus surgery. The protocol of the study was approved by the institutional ethical committee. A written informed consent was signed by the parents.

Exclusion criteria included refusal of the parents, systemic diseases affecting the nose, medical treatment affecting the study or any congenital anomalies, patients with pre-existing renal and hepatic disorders, bleeding diathesis and abnormal prothrombin time, partial thromboplastin time (PTT) or platelet counts were excluded from the study. Usage of non-steroidal anti-inflammatory drugs within 7 days of surgery was an exclusion criterion.

General anesthesia was used for all patients. However, before arrival to the operating theater, topical decongestant spray (Afrin) was applied. Oral midazolam (0.5 mg/kg, 30 min before induction) was utilized to reduce the pediatric pre-operative anxiety. Children were pre-medicated with fentanyl intra-venously 1 μg/kg before induction of anesthesia.

Face mask of the correct size was held close to the patient's face with 1% sevoflurane in oxygen 3 l/min. Increase in concentration of sevoflurane (1%) was carried out after every three breaths of patient. Concentration of sevoflurane was increased until the child was breathing 8% sevoflurane. Then, intubation was facilitated by intra-venous atracurium 0.5 mg/Kg.

Anesthesia was maintained with 2.5% sevoflurane in 100% oxygen with total flow of 3 l/min. Mechanical ventilation was at a tidal volume of 8 ml/kg, and respiratory rate was adjusted by age to give an end-tidal carbon dioxide tension of 35-40 mmHg. Lactated Ringer's solution was administered at 8 ml/kg/h. While, the inspiratory and end-tidal sevoflurane concentration had been maintained at 2.0 Vol. %.

After induction of anesthesia, the surgical site was infiltrated with 1:200.000 epinephrine for topical vasoconstriction (1 ml).

Then, children were classified randomize into two groups, 50 patients in each.

Randomization was performed using a computer based random number generator in permutated blocks of varying sizes and the assignment entered in sealed envelopes that were not opened until informed consent was obtained.

Group I: Was given after induction, intra-venous 25 mg/Kg TA diluted in 10 ml of normal saline (slow intra-venous injection in 3-5 min)Group II: Was given 10 ml of normal saline (slow intra-venous within 3-5 min).Anesthesiologists, operating personnel, and study staff were blind as to treatment groups; the same anesthesia team performed all procedures. A blinded chief nurse who did not participate in the study protocol or data collection prepared the syringes.

 Measurements



During maintenance of anesthesia, non-invasive blood pressure, and heart rate were recorded before induction of anesthesia as a base line, after induction of anesthesia, every 15 min during the surgery and then immediately after recovery.

The surgeon estimated the quality of the surgical field every 15 min during the surgical procedure with a predefined scale adapted from that of Boezaart et al. [10]

0 = No bleeding

1 = Minimal bleeding: Not a surgical nuisance and no suction required

2 = Mild bleeding: Occasional suction required, but does not affect dissection

3 = Moderate bleeding: Slightly compromises surgical field, frequent suction required

4 = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction

5 = Massive bleeding: Prevent dissection.

All procedures were performed by the same surgical team using the same technique. Cutting forceps and grabbing instruments were used, but a microdebrider was not used in the present study. The surgical team was blinded to the study protocol.

The blood loss was estimated by weighing sponges and measuring operative suction volume.

Time of operation (from induction to extubation) would be recorded.

Muscle relaxation was antagonized at the end of the surgery by neostagmine and atropine.

Side-effects of TA such as nausea, vomiting, pruritus, hematoma or hemorrhage, thrombotic complications, local infection, fever or convulsive seizure were reported.

Statistical analysis

Sample size calculation was conducted using the surgical area bleeding score as the main response variable. Power analysis identified 35 patients per group, required to detect 15% difference between groups with a power 80% and a significant level of 0.05. However, to enable detection of potential variations and avoid potential errors, fifty patients were included in each group.

Comparison of demographic data, amount of the blood loss and duration of the surgeries between the groups was carried out by the Student's t-test. Two-way analysis of variance with correction for repeated measurements was used for heart rate and blood pressure comparison. Chi-square test was used when appropriate. P<0.05 was considered significant.

 Results



A total of 100 patients scheduled for FESS were enrolled in the study. Demographic data, duration of surgeries and volume of bleeding are shown in [Table 1]. There was no significant difference between groups as regards to age, gender and weight. Meanwhile, duration of surgeries and volume of bleeding were significantly less in tranexamic group than the placebo group, P<0.0001.{Table 1}

Hemodynamic changes

Heart rate and mean arterial blood pressure were comparable in both groups P>0.05, [Table 2] and [Table 3].{Table 2}{Table 3}

Quality of the surgical field

Grading of the surgical field quality at 15 min of surgical procedure, [Table 4] revealed that 7 patients in group I had minimal bleeding, which was not a surgical nuisance and no suction required versus no one in group II, P=0.006. Meanwhile, 35 patients in group I had mild bleeding with occasional suction required, but does not affect dissection versus 26 patients in group II, P=0.064. Higher number of patients in group II than in group I had moderate bleeding slightly compromises surgical field, and frequent suction required, P=0006.{Table 4}

Grading of the surgical field quality at 30 min of surgical procedure [Table 5], revealed that 10 patients in group I had minimal bleeding, which was not a surgical nuisance and no suction required versus one patient in group II, P =0.004. Meanwhile, 37 patients in group I had mild bleeding with occasional suction required, but does not affect dissection versus 28 patients in group II, P =0.059. Higher number of patients in group II than in group I had moderate bleeding slightly compromises surgical field, frequent suction required, P <0.0001.{Table 5}

 Discussion



The development of pediatric endoscopy of the nose and sinuses, as well as diagnostic radiological tests has contributed naturally, to a quicker and more adequate diagnosis of chronic rhino sinusitis. [4] Various methods are used to reduce the bleeding to guarantee better visibility during FESS.

Pre-operative steroid administration in cases of severe nasal polyposis improves visibility due to its anti-inflammatory and anti-edematous effect. [11] Topical vasoconstrictors are applied to decrease blood loss and mucosal congestion, but hypertension and tachycardia may occur, [12] controlled hypotension is commonly used to achieve blood less operative field. [13]

Studies have looked the effect of TA as an antifibrinolytic agent in reducing bleeding during and after nasal surgery, through intra-venous, oral and nasal routes and reveled the reduction of intra-operative bleeding and improvement of the surgical field in adult patients. [14],[15] Indeed, no study has specifically examined TA and endoscopic sinus surgery in children.

In this study, the efficacy of intra-venous TA in reducing bleeding during FESS in children was examined. There was a significant improvement in quality of the surgical field, significant decrease in volume of intra-operative bleeding, and duration of surgery in TA group as compared to placebo group.

Previous studies have reported that intra-venous injection of tranexamic to patients undergoing cardiac surgery, oral surgery, liver transplantation, and prostate surgery reduced intra-operative and post-operative bleeding. [14],[15],[16],[17],[18]

One recent retrospective study provides evidence for the effective usage of TA in the field of congenital cardiac surgery in reducing blood loss in the first 48 h post-operatively and reduction of the amount red blood cells transfused. [19]

The dose of TA used in the present study was within the dose range previously found effective. [20],[21],[22] It has been proposed that therapeutic plasma concentration of tranexamic is 5-10 mg/l and is maintained for approximately 3 h. [23] Considering the relatively short duration of FESS, we assumed that a single intra-venous bolus dose of tranexamic 25 mg/Kg in children would fulfill the therapeutic goal. Albeit concerns for increased risk of post-operative complications. Similar study have utilized initial dose of 10 mg/kg followed by continuous intra-venous infusion. [16] There is a lack of dose-response in published data in the literature, where described initial bolus dosage range from 10 mg/kg to 100 mg/kg TA. In ours, continuous infusion of TA was not used after bolus dose; however, others had used continuous infusion. [21],[24]

No, reported side-effects after TA administration during the pediatric surgery; [20],[21],[25],[26],[27],[28] likewise, we did not observe complications of TA therapy in the present study.

The limitation of the present study is the exclusion of patients with the bleeding diathesis and abnormal prothrombin time, PTT or platelet counts from the study in which the use of the drug could be beneficial. Because, we aimed to study the effect of tranexamic alone on bleeding tendency and quality of the surgical field without any other factors affecting them.

In conclusion, single intra-venous bolus dose of tranexamic in children during the FESS improves quality of surgical filed and intra-operative visibility. Furthermore, it reduces intra-operative bleeding and duration of the surgery.

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