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1.
Efficacy of Continuous Suctioning in Adenoidectomy Haemostasis-Clinical Study
Epure, V., Hainarosie, R., Gheorghe, D. C.
Medicina (Kaunas, Lithuania). 2023;59(9)
Abstract
Introduction: Adenoidectomy is often the first major surgical challenge for the child's haemostatic system, and controlling intraoperative bleeding can be a challenge for the surgeon. Different methods have been used intraoperatively by surgeons in order to enhance haemostasis. The cold air effect (continuous suctioning) has been used by some surgeons during adenoidectomy; however, no documentation of its haemostatic effect has been made. Objectives: Our prospective randomised controlled study enrolled a sample of 140 children undergoing adenoidectomy, and we studied the effect of continuous suctioning on the duration of haemostasis in paediatric adenoidectomy. Materials and Methods: We evaluated the effect of using continuous suctioning during haemostasis at the end of adenoidectomy procedures, comparing variables such as total surgery time, total haemostasis time, and intraoperative blood loss, between two groups: 70 adenoidectomy procedures where no continuous suctioning was used to enhance haemostasis versus the other 70 patients where continuous suctioning was the haemostatic method employed. RESULTS After statistical analysis of the recorded data, we found that the total duration of adenoidectomy, the duration of haemostasis in adenoidectomy, and the intraoperative blood loss were significantly lower in patients in whom cold air was used for haemostasis. Intraoperative haemostasis failure (and consequent use of electrocautery for haemostasis) was more frequent in patients in whom no suctioning was used; as for the rates of postoperative primary bleeding after adenoidectomy, they were similar in both groups of patients, regardless of the technique used for haemostasis. Conclusions: The use of continuous suctioning during adenoidectomy haemostasis significantly shortens total surgical and haemostasis time, reduces intraoperative blood loss, and reduces the incidence of haemostasis failure (with the consequent need for bipolar electrocautery haemostasis).
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2.
Effectiveness and Adverse Effects of Tranexamic Acid in Bleeding during Adenotonsillectomy: A Randomized, Controlled, Double-blind Clinical Trial
Fornazieri MA, Kubo HKL, de Farias LC, da Silva AMF, Garcia ECD, Santos Gald, Pinna FR, Voegels RL
International archives of otorhinolaryngology. 2021;25(4):e557-e562
Abstract
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.
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Selection of the optimal dosage of tranexamic acid to reduce blood loss during pediatric cleft palate surgery
Shafa A, Shetabi H, Adineh-Mehr L, Bahrami K
Tzu chi medical journal. 2021;33(2):181-187
Abstract
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.
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Effects of the Two Doses of Dexmedetomidine on Sedation, Agitation, and Bleeding During Pediatric Adenotonsillectomy
Shafa A, Aledavud H, Shetabi H, Shahhosseini S
Anesthesiology and pain medicine. 2021;11(5):e118424
Abstract
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.
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Efficacy Of Prophylactic Antibiotics In Reducing Posttonsillectomy Haemorrhage
Sheikh NA, Nadeem K
J Ayub Med Coll Abbottabad. 2020;32(1):94-98
Abstract
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.
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Efficacy and toxicities of low-temperature plasma radiofrequency ablation for the treatment of laryngomalacia in neonates and infants: a prospective randomized controlled trial
Xu H, Chen F, Zheng Y, Li X
Annals of translational medicine. 2020;8(21):1366
Abstract
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.
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7.
Comparison of Ibuprofen vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy: A Noninferiority Randomized Clinical Trial
Diercks GR, Comins J, Bennett K, Gallagher TQ, Brigger M, Boseley M, Gaudreau P, Rogers D, Setlur J, Keamy D, et al
JAMA otolaryngology-- head & neck surgery. 2019
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Abstract
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 [4] 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.
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Postoperative pain and bleeding after adenotonsillectomy versus adenotonsillotomy in pediatric obstructive sleep apnea: an RCT
Borgstrom A, Nerfeldt P, Friberg D
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
Abstract
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).
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The Hemostatic Efficacy of Hydrogen Peroxide Irrigation to Control Intraoperative Bleeding in Adenoidectomy
Altun H, Hanci D, Kumral TL, Uyar Y
Turkish archives of otorhinolaryngology. 2018;56(4):193-198
Abstract
Objective: Although adenoidectomy is generally accepted as a safe procedure, intraoperative hemorrhage is still the most common and potentially life-threating complication, especially in pediatric patients. We evaluated the clinical effect of intraoperative hydrogen peroxide irrigation with respect to hemostasis and operation times in pediatric adenoidectomy. Methods: This was a prospective, randomized, double-blind study to investigate hydrogen peroxide solution in hemostasis in pediatric patients undergoing adenoidectomy. The patient, the surgeon, and the study nurse were blinded to the surgical technique used. Results: One hundred seventeen (56 males and 61 females) consecutive pediatric patients with a mean age of 5.46+/-1.19 years were included in the study. There were 58 patients in the hydrogen peroxide group (median age: 6 years, mean age: 5.62+/-1.28 years) and 59 patients in the control group (median age: 5 years, mean age: 5.31+/-1.07 years). No significant difference was observed between the two groups with respect to age (p=0.151), gender (p=0.646), or adenoid size (p=0.767). On the other hand, the difference between the groups with respect to operation and hemostasis times was found to be statistically significant (p<0.001 for both). The average operation times were 8.67+/-0.48 min in the hydrogen peroxide group and 12.30+/-0.69 min in the control group. The average hemostasis times were 3.67+/-0.27 min in the hydrogen peroxide group and 5.73+/-0.31 min in the control group. Conclusion: Hydrogen peroxide solution can be effectively used in adenoidectomy for reducing intraoperative blood loss and for economic benefits.
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Effects of tranexamic acid during endoscopic sinsus surgery in children
Eldaba AA, Amr YM, Albirmawy OA
Saudi journal of anaesthesia. 2013;7((3):):229-33.
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.