Effectiveness and Adverse Effects of Tranexamic Acid in Bleeding during Adenotonsillectomy: A Randomized, Controlled, Double-blind Clinical Trial
International archives of otorhinolaryngology. 2021;25(4):e557-e562
Introduction Intra and postoperative bleeding are the most frequent and feared complications in adenotonsillectomy (AT). Tranexamic acid (TXA), which is known for its antifibrinolytic effects, has a proven benefit in reducing bleeding in hemorrhagic trauma and cardiac surgery; however, the effectiveness and timing of its application in AT have not yet been established. Objectives We aimed to evaluate the efficacy of TXA in controlling bleeding during and after AT and assess its possible adverse effects in children. Methods The present randomized, controlled, double-blind clinical trial included 63 children aged 2 to 12 years. They were randomly assigned to receive either intravenous TXA (10 mg/kg) or placebo 10 minutes before surgery. The volume of intraoperative bleeding, presence of postoperative bleeding, and adverse effects during and 8 hours after the surgery were assessed. Results No difference in bleeding volume was noted between the 2 groups (mean, 122.7 ml in the TXA group versus 115.5 ml in the placebo group, p = 0.36). No intraoperative or postoperative adverse effects were noted because of TXA use. Furthermore, no primary or secondary postoperative bleeding was observed in any of the participants. Conclusion In our pediatric sample, TXA (10 mg/kg) administration before AT was safely used, without any adverse effects. It did not reduce the bleeding volume in children during this type of surgery. Future studies should assess the use of higher doses of TXA and its administration at other time points before or during surgery.
Selection of the optimal dosage of tranexamic acid to reduce blood loss during pediatric cleft palate surgery
Tzu chi medical journal. 2021;33(2):181-187
OBJECTIVE The aim of the present study was to evaluate and select the optimal dosage of tranexamic acid (TXA) to reduce blood loss during cleft palate surgery in children. MATERIALS AND METHODS This randomized double-blind clinical trial was performed on 80 children under 3 years of age that were candidates for cleft palate surgery. These children were divided into four groups as follows: the first, second, and third groups received 5, 7.5, and 10 mg/kg of TXA, respectively. Moreover, the fourth group was considered as the control group. Before induction of anesthesia and then every 15 min during the surgery, some parameters such as mean arterial pressure, heart rate, SpO(2), and ETCO(2) were recorded. Moreover, the amount of blood loss during the surgery, the level of surgeon's satisfaction, and incidence rate of complications were assessed and recorded. RESULTS The amount of blood loss during the surgery in TXA groups receiving dosages of 5, 7.5, and 10 mg/kg with the means of 63.75 ± 10.62, 61.25 ± 15.03, and 61.00 ± 14.29, respectively, was significantly lower than that of the control group with the mean of 92.25 ± 19.83 (P < 0.001). Moreover, no significant difference was found between the three groups receiving TXA dosages in terms of the amount of blood loss, the level of surgeon's satisfaction (P > 0.05). CONCLUSION According to the results of the present study, all three dosages of TXA had a significant role in reducing blood loss in cleft palate surgery. Given the potential for increased risk of side effects from the drug, it seems safe to use the minimal dosage of this drug to control and reduce blood loss during cleft palate surgery in children <3 years of age.
Post-Tonsillectomy Ibuprofen: Is There a Dose-Dependent Bleeding Risk?
The Laryngoscope. 2021
OBJECTIVES/HYPOTHESIS Post-tonsillectomy hemorrhage (PTH) is a potentially life-threatening complication. A recent meta-analysis suggests that ibuprofen may increase the risk of PTH. The aims of this study were to 1) re-evaluate the effect of ibuprofen on PTH given additional recent evidence and 2) to evaluate a potential dose effect of ibuprofen. STUDY DESIGN Meta-analysis and meta-regression; single-institution retrospective review. METHODS We conducted a systematic review of the literature and a meta-analysis of 12 studies comparing postoperative ibuprofen analgesia to non-nonsteroidal anti-inflammatory drug (NSAID) controls. Next, we performed a meta-regression analysis to assess for an effect of dose, if any, on rates of PTH. Five studies specifying a dose of 5 mg/kg (828 patients, 1,411 controls) and 7 studies using 10 mg/kg (5,633 patients, 7,656 controls) were included. We then conducted a novel single-institution, retrospective review of data for 1,046 patients prescribed intermediate-dose 7.5 mg/kg ibuprofen. RESULTS Ibuprofen was not associated with an increased rate of PTH (log odds ratio [OR], 0.21; 95% confidence interval [CI] -0.15, 0.57). Meta-regression showed that ibuprofen dose (5 and 10 mg/kg) did not have a statistically significant effect on PTH (OR, 1.32; 95% CI 0.30, 5.84). Uncontrolled, aggregate rates of PTH across all studies were 2.29% (N = 828) for 5 mg/kg and 4.65% (N = 5,633) for 10 mg/kg dosing. The rate of secondary hemorrhage in patients prescribed 7.5 mg/kg ibuprofen was 3.10% (N = 1,046). CONCLUSION We found no statistically significant increased risk of PTH when ibuprofen is prescribed at the low or high range of commonly used clinical dosages, compared to a non-ibuprofen regimen. Further studies with less heterogeneity are needed to determine if there is a clinically relevant dose-dependent difference in PTH with ibuprofen. LEVEL OF EVIDENCE 3 Laryngoscope, 2021.
Efficacy Of Prophylactic Antibiotics In Reducing Posttonsillectomy Haemorrhage
J Ayub Med Coll Abbottabad. 2020;32(1):94-98
BACKGROUND This study aims toward establishing the impact of prophylactic pre-operative antimicrobial therapy on tonsillectomy related haemorrhage. METHODS In this randomized controlled trial conducted at Combined Military Hospital, Abbottabad from January 2017 till August 2019, 121 children and adult patients who had consented and had undergone tonsillectomy were evaluated for procedure related haemorrhage. RESULTS Incidence rate of secondary posttonsillectomy haemorrhage and need for re-hospitalization was significantly less in patients who had completed pre-operative prophylactic antibiotics. Patient-reported secondary haemorrhage was recorded in 4.59% (n=9) cases who did not receive pre-operative antibiotic prophylaxis, thereby increasing morbidity and prolonging hospital stay. Secondary post-operative bleeding only occurred in 1.18% (n=2) patients who received appropriate pre-operative anti-microbial prophylaxis. CONCLUSIONS We strongly imply that prophylactic pre-operative antibiotics reduce procedure related complications in all patients undergoing tonsillectomy.
Efficacy and toxicities of low-temperature plasma radiofrequency ablation for the treatment of laryngomalacia in neonates and infants: a prospective randomized controlled trial
Annals of translational medicine. 2020;8(21):1366
BACKGROUND Laryngomalacia is the most common cause of stridor in neonates and infants, and supraglottoplasty is the mainstay of surgical treatment. Although low-temperature plasma radiofrequency ablation (LTP-RFA) using coblation technology has been used for treating laryngomalacia, it is still lack of high-quality clinical evidence. Therefore, we conduct this prospective randomized study to clearly define the role of LTP-RFA for the treatment of laryngomalacia in neonates and infants. METHODS Between Jan 2017 and Dec 2019, a total of 89 children with laryngomalacia were included for analysis. All patients were initially stratified according to the severity of laryngomalacia. Patients with severe laryngomalacia were randomly assigned to receive LTP-RFA or traditionally surgical supraglottoplasty, while patients with moderate laryngomalacia were assigned to LTP-RFA or observation. The primary end point was the efficacy and toxicities of LTP-RFA by assessing the changes of clinical score and visual analogue scale (VAS) symptom score. The total score was the combination of clinical score with VAS score. RESULTS Of the 89 children, 40 children presented with severe laryngomalacia, and the remaining 49 children were diagnosed as moderate laryngomalacia. The median age was 68 days (range, 19 to 337 days). For children with severe laryngomalacia, our results showed that LTP-RFA treatment significantly reduced the operative time (5.55±1.66 vs. 18.7±5.31 min, P<0.001), length of hospital stay (6.71±1.15 vs. 7.95±1.55 days, P=0.008) and the amount of intraoperative hemorrhage (1.71±1.79 vs. 4.90±1.82, P<0.001) when compared to traditionally surgical supraglottoplasty, while the treatment efficacy was comparable between LTP-RFA and traditionally surgical supraglottoplasty in terms of changed total score (P=0.322), changed clinical score (P=0.135) and changed VAS symptom score (P=0.559). Additionally, for children with moderate laryngomalacia, LTP-RFA treatment significantly improved the symptom evaluated by total score (P<0.001), clinical score (P<0.001) and VAS symptom score (P<0.001) in comparison with the observation group. Post-operative pneumonia was observed in 10 patients. No surgical related death was reported. CONCLUSIONS The present study indicated that LTP-RFA was an effective treatment option for both severe and moderate laryngomalacia in neonates and infants with a low intraoperative complication. Long-term outcomes of LTP-RFA for laryngomalacia would be reported in further studies.
Haemostasis and analgesia with autologous platelet-rich plasma in tonsillectomy
The Journal of laryngology and otology. 2019;:1-7
OBJECTIVE A single-centre, single-blinded prospective experimental study was conducted to determine the effectiveness of autologous platelet-rich plasma applied to the tonsillar bed post-operatively in reducing post-operative pain and haemorrhage. METHODS Platelet-rich plasma, prepared prior to surgery, was applied with calcium gluconate to one randomly chosen tonsillar fossa. Pain and haemorrhage were analysed, using a visual analogue scale and a pre-defined grading scale respectively, four times on the day of surgery at 2-hourly intervals, and thrice on the following day. RESULTS The pain score and haemorrhage grade on the test side were lower than on the control side. These findings were statistically significant. CONCLUSION This pilot study, conducted in India, revealed valid positive results for a promising new technology. The manual preparation of platelet-rich plasma could be automated in the future to allow a larger sample size.
Postoperative pain and bleeding after adenotonsillectomy versus adenotonsillotomy in pediatric obstructive sleep apnea: an RCT
European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery. 2019
PURPOSE Our previous randomized controlled trial (RCT) of children with obstructive sleep apnea (OSA) showed no significant differences between adenotonsillectomy (ATE) and adenotonsillomy (ATE) in improving nocturnal respiration and symptoms after one year. This is the continuous report with the evaluation of postoperative morbidity concerning bleeding and pain. METHODS A double-blinded RCT including 79 children, aged 2-6 years, with moderate to severe OSA, randomized to either ATE (n = 40) or ATT (n = 39). From one to ten days postoperatively, parents filled in a logbook with six pain-related outcomes (parent and child grading pain at different levels, days of analgesic use and return to normal diet). Peri- and postoperative bleeding were also registered. RESULTS 63 patients (80%) returned the logbook. There were significant differences between groups in only two of the six pain-related outcomes in favor of the ATT group; first day when the children graded themselves as pain free (p = 0.021, Log Rank Test), and first day the caregiver estimated pain VAS ≤ 5 (p = 0.007, Log Rank Test). Two (5%) cases of postoperative bleeding occurred in the ATE group, one of which needed a return to theatre. No case of postoperative bleeding was seen in the ATT group. CONCLUSIONS The results from this RCT are in line with previous comparative studies between ATT and ATE. Children operated with ATT had significantly less postoperative pain in one-third of the outcomes, and less bleeding than ATE. However, as the differences in morbidity between the surgical methods were minor the clinical significance is uncertain. TRIAL REGISTRATION This study was approved by the Swedish Regional Ethics Board in Stockholm, Sweden (Dnr 2011/925-32 and 2013/2274-32) and registered at ClinicalTrials.gov (Trial registration number NCT01676181).
Hot nasal packing with hot saline irrigation for hemostasis after adenoidectomy: A prospective randomized controlled study
International journal of pediatric otorhinolaryngology. 2019;130:109792
OBJECTIVE This study aimed to investigate the efficacy of hot posterior nasal packing and hot saline irrigation in bleeding control after adenoidectomy. METHODS A total of 130 patients scheduled for adenoidectomy were included in the study, and randomized into two groups at the beginning of the surgical operation. After adenoidectomy, saline impregnated tampon, and saline irrigation at room temperature (22 degrees C) was applied to the patients in one group while 50 degrees C saline impregnated tampon and saline irrigation at the same temperature were applied to the patients in the other group. We recorded hemostasis for up to 3 min after tamponade for bleeding control, and the amount of bleeding into the nasopharynx. RESULTS The age of the patients ranged from 1.5 to 13 years (mean +/- SD: 6.07 +/- 3.08 years, and 5.33 +/- 2.55 years, 22 degrees C and 50 degrees C saline irrigation groups, respectively). There were 37 males and 28 females in the 22 degrees C saline group, while 34 males and 31 females in the 50 degrees C saline group. When comparing the two groups, there was no statistically significant difference in terms of duration of hemostasis (p = 0.64). However, bleeding scores at 2 nd min after the tamponade were significantly lower in the 50 degrees C saline group (p = 0.007). The amount of bleeding in the 50 degrees C saline group was also significantly lower than the 22 degrees C saline group (p = 0.015). CONCLUSION In this study, application of 50 degrees C saline impregnated tampon, and hot saline irrigation was found to be more effective in the control of bleeding after adenoidectomy by reducing the amount of bleeding compared to 22 degrees C saline impregnated tampon application and saline irrigation at 22 degrees C. However, hot nasal packing and hot saline irrigation did not affect duration of hemostasis and cauterization.
Does suturing tonsil pillars post-tonsillectomy reduce postoperative hemorrhage?: A literature review
International journal of pediatric otorhinolaryngology. 2018;117:204-209
OBJECTIVE Literature review comparing post-tonsillectomy hemorrhage in pediatric and adult patients with and without suturing tonsil pillars to investigate whether suturing tonsil pillars reduces the risk of post-tonsillectomy hemorrhage. REVIEW METHODS Online journal databases were searched using the key phrases "post tonsillectomy hemorrhage", "post tonsillectomy bleed", and "tonsil pillar suture". 10 published studies were found regarding tonsil pillar suturing, four directly related to postoperative bleeding and five focusing on postoperative pain reduction. There was one study that evaluated both pain and bleeding. The pain reduction studies were comprised of 225 patients while the postoperative bleeding studies included 3987 patients. CONCLUSIONS Suturing tonsil pillars after tonsillectomy may be beneficial after cold tonsillectomy. IMPLICATIONS FOR PRACTICE Post-operative bleeding is one of the most common complications that can result in increased patient distress and hospitalization. In this article, we provide a literature review of tonsil pillar suturing and post-tonsillectomy hemorrhage. Our study suggests suturing the tonsil pillars immediately post-tonsillectomy may reduce the risk of severe post-operative bleeding requiring return to the operating room for certain patients.
Comparing Cold/Liquid Diet vs Regular Diet on Posttonsillectomy Pain and Bleeding
Otolaryngology--Head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery. 2018;:194599818788555.
Objective Tonsillectomy is a common operation; however, there are controversial opinions regarding the posttonsillectomy diet. The aim of this study was to compare the effects of cold/liquid diet vs regular diet on posttonsillectomy pain and bleeding. Study Design Prospective randomized controlled trial. Setting Tertiary referral center. Subjects and Methods In total, 194 children who underwent tonsillectomy (with or without adenoidectomy) were randomly allocated into 2 groups. A total of 100 patients were allocated in the cold/liquid diet, and 94 patients were allocated in the regular diet group. Pain score was recorded for the first 7 days, and rate of hemorrhage was recorded for 10 days after surgery. Results The participants' age range was 3 to 17 years. The mean pain score level in the regular diet group after breakfast, lunch, and dinner was not statistically significant in comparison with the cold/liquid diet group. One patient in the regular diet group was admitted to the hospital due to secondary bleeding, but it stopped without any intervention. Conclusion Most otolaryngologists believe in dietary restrictions following tonsillectomy. However, there is much controversy regarding posttonsillectomy dietary advice in the literature. In addition, only a few randomized clinical trials have focused on this subject. We found that there was no difference between regular diet and cold/liquid diet in terms of posttonsillectomy pain and bleeding. Hence, we do not recommend a limited posttonsillectomy diet.