What is the most appropriate hemostatic material during pediatric adenoidectomy? A prospective comparative randomized double-blinded controlled study
International journal of pediatric otorhinolaryngology. 2022;156:111095
OBJECTIVES To evaluate the effect of different hemostatic materials used in adenoidectomy operations to improve the quality of life with the most negligible hazardous impact on pediatric health. STUDY DESIGN a prospective, case-series, randomized, controlled, double-blinded study. SETTING All adenoidectomy surgeries were performed between September 2016 to December 2019 at tertiary referral institutions. PATIENTS AND METHODS 519 patients were included in five groups. Adenoidectomy was performed under general anesthesia, with the following hemostatic procedures: adrenaline, tranexamic acid, hydrogen peroxide, xylometazoline, and saline (as a control group). The five groups were compared regarding the intraoperative blood loss, surgery duration, need for more hemostatic steps, postoperative reactionary and secondary bleedings, postoperative pain and halitosis, and one-year outcome. RESULTS The four procedures were effective in reducing the blood loss by 19.86%, 11.7%, 30.95%, and 18.91%, respectively, in comparison to the control group. The surgical duration was reduced by 27.65%, 17.86%, 48.11%, and 23.88%, respectively. The need for other hemostatic steps was the least in the hydrogen peroxide group. There was no significant difference between the five groups regarding reactionary bleeding, secondary bleeding, one-week pain, one-month pain, one-month halitosis, and one-year complications. On the other side, hydrogen peroxide had the least one-week halitosis and first-day pain among the five groups. Also, it had the least intraoperative blood loss and surgery duration. CONCLUSIONS Hydrogen peroxide showed to be the best choice to control hemostasis during an adenoidectomy. It can decrease blood loss and surgery duration with less need for other hemostatic steps. It can improve the patient's quality of life without significant postoperative complications. Xylometazoline was studied for the first time as a hemostatic material during adenoidectomy with good satisfying results.
Coblation Versus Bipolar Diathermy Hemostasis in Pediatric Tonsillectomy Patients: Systematic Review and Meta-Analysis
This study aimed to compare the outcomes of coblation versus bipolar diathermy in pediatric patients undergoing tonsillectomy. A systematic review and meta-analysis were performed per the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Guidelines. An electronic search of information was conducted to identify all Randomized Controlled Trials (RCTs) comparing the outcomes of coblation versus bipolar in pediatric patients undergoing tonsillectomy. Primary outcome measures were intraoperative bleeding, reactionary hemorrhage, delayed hemorrhage, and post-operative pain. Secondary outcome measures included a return to a normal diet, effects on the tonsillar bed, operation time, and administration of analgesia. Fixed and random-effects models were used for the analysis. Seven studies enrolling 1328 patients were identified. There was a significant difference between coblation and bipolar groups in terms of delayed hemorrhage (Odds Ratio [OR] = 0.27, P = 0.005) and post-operative pain (standardized mean difference [MD] = -2.13, P = 0.0007). Intraoperative bleeding (MD = -43.26, P = 0.11) and reactionary hemorrhage did not show any significant difference. The coblation group improved analgesia administration, diet and tonsillar tissue recovery, and thermal damage for secondary outcomes. No significant difference was reported in terms of operation time. In conclusion, coblation is comparable to a bipolar technique for pediatric patients undergoing tonsillectomy. It improves postoperative pain and delayed hemorrhage and does not worsen intraoperative bleeding and reactionary hemorrhage.
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.
Monopolar electrocautery tip vs plasma ablation in tonsillotomy: A randomized case-control study comparing outcomes in pediatric population
International Journal of Pediatric Otorhinolaryngology. 2021;143:110655
BACKGROUND The objective of this study was to compare the low-priced monopolar electrocautery to the high-priced, worldwide used, plasma ablation in tonsillotomy among children aged between three and twelve years, suffering from obstructive breathing disorders (OBD), with respect to post-operative pain, bleeding and related morbidities. METHODS A randomized case-control study was conducted in the Eye and Ear Hospital International- Lebanon. 103 children aged between three and twelve years suffering from OBD secondary to tonsillar hypertrophy were randomly assigned into two groups. Post-operative pain was evaluated using age-adequate validated scales: "FLACC-R" (Face, Legs, Activity, Cry, Consolability-Revised) for children aged less than five years, and "Wong Baker faces" for older children. Additional post-operative outcomes were evaluated using Pain-PROM (Patient reported Pain-Related Outcome Measures) and TAHSI (Tonsil and Adenoid Health Status Instrument) scales. RESULTS Significantly, higher rates of patients who underwent tonsillotomy via plasma ablation technique used analgesics and had severe pain compared to the monopolar electrocautery group. A longer operative duration was significantly associated with higher pain scores, and the plasma ablation technique yielded significantly higher operative mean durations. 10 days post-operatively, a significantly higher percentage of children reported an overall high pain severity and more than expected overall pain when using the plasma ablation technique compared to the monopolar electrocautery one. Overall bleeding rates were similar. No difference was reported one month post-operatively. CONCLUSION When compared to plasma ablation, monopolar electrocautery, can provide the same efficiency in relieving OBD in healthy children, with equal overall bleeding rates, but significantly lower cost, operating time, pain scores and need for analgesics.
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.
Effects of the Two Doses of Dexmedetomidine on Sedation, Agitation, and Bleeding During Pediatric Adenotonsillectomy
Anesthesiology and pain medicine. 2021;11(5):e118424
BACKGROUND Due to the importance of dexmedetomidine and its different dosages, here, we aimed to investigate and compare the effectiveness of the doses of 1 µg/kg and 2 µg/kg of dexmedetomidine in sedation, agitation, and bleeding in pediatrics undergoing adenotonsillectomy. METHODS This double-blinded randomized clinical trial was performed on 105 pediatric patients that were candidates for adenotonsillectomy. Then, the patients were divided into three groups receiving dexmedetomidine at a dose of 2 µg/kg, diluted dexmedetomidine at 1 µg/kg, and normal saline. The drugs were administered 15 minutes before operations via the intravenous method. The duration of extubation, mean arterial pressure (MAP), heart rate (HR), and SPO(2) in the recovery were recorded. We also collected data regarding patients' sedation and agitation every 15 minutes. RESULTS Our data showed no significant differences between the groups of patients regarding MAP, HR, and SPO(2). However, the mean sedation score was significantly higher in patients receiving dexmedetomidine (2 µg/kg), and this score was lowest in the control group at the time of entrance to the recovery room. The patients that received dexmedetomidine at a dose of 1 µg/kg had the lowest agitation score after 45 minutes of being in the recovery room, and the patients treated with dexmedetomidine at a dose of 2 µg/kg had the lowest agitation score after 60 minutes of being in the recovery compared to other groups of patients. CONCLUSIONS The use of the doses of 1 µg/kg and 2 µg/kg of dexmedetomidine was associated with proper sedation and a significant reduction in agitation. The patients also had lower amounts of bleeding. We recommend that anesthesiologists should pay more attention to dexmedetomidine at a dose of 2 µg/kg, especially in pediatric surgical procedures.
Bipolar loop device versus bipolar diathermy for tonsillectomy: A pilot randomized controlled trial
International Journal of Pediatric Otorhinolaryngology. 2021;141:110505
OBJECTIVE Tonsillectomy is one of the most common surgeries performed in the pediatric population. Although different forms of instruments and various methods are used to perform tonsillectomy, none of them is still recognized as the best global technique. This study aimed to compare the outcomes of the new Bipolar Loop tonsillectomy versus bipolar diathermy technique. METHODS This study is a pilot randomized clinical trial and was conducted on 40 pediatric patients who were the candidate of tonsillectomy. Patients were divided into two groups of Bipolar Loop or bipolar diathermy. Operation time, intraoperative bleeding, tonsillar fossa wound, postoperative complications, and duration of return to normal diet were evaluated in the current study. RESULTS In both of the Bipolar Loop and bipolar diathermy groups, no significant difference was found in terms of sex, age, and weight. The average amount of the operative time, intra-operative blood loss, and postoperative pain loss were significantly less in the Bipolar Loop group (P < .001). In addition, the tonsillar fossa wound healing scores were significantly better (on the 14th day, P = 0.009). However, there was no significant difference between the two groups in terms of postoperative bleeding, duration of return to a normal diet, and postoperative symptoms of fever, otalgia, or voice change between the groups. CONCLUSION The study showed that blood loss and postoperative pain through day 7 were significantly less in the Bipolar Loop group. Tonsillectomy with Bipolar Loop can be recommended as one of the methods for tonsillectomy, especially in pediatric patients.
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 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.
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.