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.
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.
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.
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.
Comparison of Ibuprofen vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy: A Noninferiority Randomized Clinical Trial
JAMA otolaryngology-- head & neck surgery. 2019
Importance: Ibuprofen is an effective analgesic after tonsillectomy alone or tonsillectomy with adenoidectomy, but concerns remain about whether it increases postoperative hemorrhage. Objective: To investigate the effect of ibuprofen compared with acetaminophen on posttonsillectomy bleeding (PTB) requiring surgical intervention in children. Design, Setting, and Participants: A multicenter, randomized, double-blind noninferiority trial was conducted at 4 tertiary medical centers (Massachusetts Eye and Ear Infirmary, Boston; Naval Medical Center, San Diego, California; Naval Medical Center, Portsmouth, Virginia; Madigan Army Medical Center, Tacoma, Washington). A total of 1832 children were assessed for eligibility (presence of sleep-disordered breathing or obstructive sleep apnea, adenotonsillar hypertrophy, or infectious tonsillitis undergoing extracapsular tonsillectomy by electrocautery). Of these, 1091 were excluded because they did not meet eligibility criteria (n = 681) or refused to participate (n = 410); thus, 741 children aged 2 to 18 years undergoing tonsillectomy alone or tonsillectomy with adenoidectomy were enrolled between May 3, 2012, and January 20, 2017. Interventions: Participants were randomized to receive ibuprofen, 10 mg/kg (n = 372), or acetaminophen, 15 mg/kg (n = 369), every 6 hours for the first 9 postoperative days. Main Outcomes and Measures: Rate and severity of posttonsillectomy bleeding were recorded using a postoperative bleeding severity scale: type 1 (bleeds that were observed at home or evaluated in the emergency department without further intervention), type 2 (bleeds that required readmission for observation), and type 3 (bleeds that required a return to the operating room for control of hemorrhage). Type 3 bleeding was the main outcome measure. The noninferiority margin was set at 3%, and modified intention-to-treat analysis was used. Results: Of the 741 children enrolled, 688 children (92.8%) (median [interquartile range] age, 5  years; 366 boys [53.2%]) received the study medication and were included in a modified intention-to-treat analysis. The rate of bleeding requiring operative intervention was 1.2% in the acetaminophen group and 2.9% in the ibuprofen group (difference, 1.7%; 97.5% CI upper limit, 3.8%; P = .12 for noninferiority). There were no significant adverse events or deaths. Conclusions and Relevance: This study could not exclude a higher rate of severe bleeding in children receiving ibuprofen after tonsillectomy alone or tonsillectomy with adenoidectomy. This finding should be considered when selecting a postoperative analgesic regimen. Further studies are needed to understand if bleeding risk is affected when ibuprofen is used for a shorter duration or in combination with acetaminophen for postoperative analgesia. Trial Registration: ClinicalTrials.gov identifier: NCT01605903.
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).