0
selected
-
1.
Absorbable Hemostatic Pack Effect After Primary Incisor Extraction: A Pilot Study and Introduction of a Novel Scale to Assess Post-Operative Bleeding
Mattox SL, Hammersmith KJ, Peng J, Casamassimo PS, Townsend JA
The Journal of clinical pediatric dentistry. 2021;45(2):67-73
Abstract
OBJECTIVES This pilot study compared hemostatic pack (HP) application with no intervention following extraction of maxillary primary incisors in healthy children for effect on bleeding time and influence of patient or tooth variables utilizing a novel scale for assessment of bleeding following extraction. STUDY DESIGN A novel scale was created to assess bleeding after extraction. This scale was utilized in a randomized, split mouth study of healthy children ages 2-7 years old requiring extraction of at least 2 primary maxillary incisors under general anesthesia. One extraction site was randomly assigned to receive HP and the other had no hemostatic measures. Post-operative bleeding was rated at 2, 10, and 15 minutes post-extraction. Other variables recorded included age, sex, periapical radiolucency, presence of fistula, swelling, discoloration, intraoral stabilization device used, and vital signs at two time intervals. Pre-operative radiographs were reviewed for root resorption and periapical radiolucency. RESULTS AND CONCLUSIONS Twenty-five patients provided 50 teeth. Hemostatic pack had a significant effect on reducing bleeding at each time point and that effect did not change over time. Age, sex, tooth pain, post-extraction heart rate, blood pressure, discoloration, amount of resorption, and presence of a periapical radiolucency had no significant effect on bleeding. The proposed bleeding scale had good intra-rater reliability and could be useful in future studies, once validated.
-
2.
Effect of tranexamic acid on markers of inflammation in children undergoing craniofacial surgery
Fenger-Eriksen C, Rasmussen M, Juul N, Krog J, Hvas AM
Acta anaesthesiologica Scandinavica. 2020
Abstract
BACKGROUND Tranexamic acid (TXA) reduces blood loss and transfusion requirements during craniosynostosis surgery in small children. Possible interaction from TXA on the inflammatory system is unknown. OBJECTIVE To evaluate the effect of TXA on a wide range of inflammatory markers in children receiving TXA in a randomized, blinded and placebo controlled study design. METHODS Thirty children undergoing craniosynostosis surgery with significant blood loss received TXA (bolus dose of 10 mg kg(-1) followed by 8 hours continuous infusion of 3 mg kg(-1) h(-1) ) or placebo in a randomized, double-blinded study design. Using a new proximity extension assays employing a panel of inflammatory biomarkers samples was used for analysis of blood samples obtained preoperatively, 4h and 24 h after operation. RESULTS Ninety-two inflammatory parameters were measured. TXA did not affect any of the measured parameters as compared with placebo. Among 34 of the 92 pro- and antiinflammatory parameters investigated changes were observed between preoperative, 4 h or 24 h respectively, reflecting immune activation during surgical stress. CONCLUSION TXA administration in a low-dose regimen including bolus followed by 8h infusion during craniosynostosis surgery did not change any of 92 inflammatory markers as compared with placebo.
-
3.
Effectiveness of topical haemocoagulase as a haemostatic agent in children undergoing extraction of primary teeth: a split-mouth, randomised, double-blind, clinical trial
Swamy DF, Barretto ES, Rodrigues JSL
European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry. 2019
Abstract
AIM: To assess the effectiveness of topically-administered haemocoagulase (batroxobin) (HC) following dental extractions in children. DESIGN Split-mouth design, where either HC (test) or Normal Saline (control) (NS) was administered to children (5-9 years) requiring bilateral extractions of primary molars. Participants were randomised to (i) extraction sequence; (ii) test-solution administered thereafter. OUTCOME MEASURE time taken (in seconds) for complete cessation of bleeding. RESULTS Thirty participants completed the trial receiving HS (n = 30) and NS (n = 30). No adverse events were reported. Time to bleeding cessation was lower in HS group (82.5 +/- 13.99 s) than NS group (240.5 +/- 54.34 s). Difference between groups (paired t test) was statistically very highly significant (P = 0.000). CONCLUSION Topical HC produced significant reductions in time for haemostasis and was clinically effective in controlling haemorrhage from extraction wounds in children. HC may be favourably utilised by paediatric dentists, especially with pre-cooperative or special-healthcare-needs patients, improving patient care.
-
4.
Clinical and radiographic evaluation of the efficacy of sodium hypochlorite as a haemostatic agent compared with physiologic saline on the success of calcium hydroxide pulpotomies in primary molars: an in vivo study
Hemavathi, Nagarathna J, Srinath SK, Hiremath MC
European Archives of Paediatric Dentistry : Official Journal of the European Academy of Paediatric Dentistry. 2018;19((6):):423-430.
Abstract
AIM: To evaluate, via clinical and radiographic assessment; the success of calcium hydroxide pulpotomies with the application of 5% sodium hypochlorite as a haemostatic agent compared with physiologic saline in primary molars and to evaluate if there is improved efficacy of increased concentration of sodium hypochlorite application in calcium hydroxide pulpotomies. METHODS Thirty children aged between 3 and 8 years, having at least two vital primary molars (split mouth design) with deep carious lesions with probable exposure of the pulp, were selected. The 60 teeth were randomly allocated to two groups and conventional calcium hydroxide pulpotomies were performed on all selected primary molars in both the groups. A cotton pellet saturated with 5% sodium hypochlorite was applied to teeth as a haemostatic agent in group A (experimental) for 30 s while physiologic saline was used to manage haemorrhage in group B (control). Teeth were restored with preformed metal crowns (PMC) in both the groups after the procedure. Evaluation for clinical and radiological success of calcium hydroxide pulpotomies was performed at baseline, 1, 3, 6 and 12 months follow-up. RESULTS Statistical analysis did not show (p > 0.05) significant differences in the clinical and radiological success rates of calcium hydroxide pulpotomies in both the groups at 12 months follow-up. CONCLUSION The increased concentration of sodium hypochlorite showed lower success rate in calcium hydroxide pulpotomies when compared to physiologic saline, although this difference was not statistically significant.
-
5.
Effects of Tranexamic Acid Based on its Population Pharmacokinetics in Pediatric Patients Undergoing Distraction Osteogenesis for Craniosynostosis: Rotational Thromboelastometry (ROTEM(TM)) Analysis
Kim EJ, Kim YO, Shim KW, Ko BW, Lee JW, Koo BN
International Journal of Medical Sciences. 2018;15((8)):788-795.
Abstract
Background: Distraction osteogenesis for craniosynostosis is associated with significant hemorrhage. Additionally, patients usually require several transfusions. Tranexamic acid (TXA) is effective for reducing blood loss and the need for transfusions during surgeries. However, the significance of TXA infusion has not been thoroughly described yet. Methods: Forty-eight children undergoing distraction osteogenesis for craniosynostosis were administered intraoperative TXA infusion (loading dose of 10 mg/kg for 15 min, followed by continuous infusion at 5 mg/kg/h throughout surgery; n = 23) or normal saline (control, n = 25). Rotational thromboelastometry (ROTEM(TM)) was conducted to monitor changes in coagulation perioperatively. Results: Blood loss during surgery was significantly lower in the TXA-treated group than it was in the control group (81 vs. 116 mL/kg, P = 0.003). Furthermore, significantly fewer transfusions of red blood cells and fresh frozen plasma were required in the TXA group. In the control group, clotting time during the postoperative period was longer than it was during the preoperative period. Similarly, clot strength was weaker during the postoperative period. D-dimer levels dramatically increased in the control group compared with the TXA group after surgery. The duration of mechanical ventilation and the number of postoperative respiratory-related complications were significantly greater in the control group than they were in the TXA group. Conclusions: TXA infusion based on population pharmacokinetic analysis is effective in reducing blood loss and the need for transfusions during the surgical treatment of craniosynostosis. It can also prevent the increase in D-dimer levels without affecting systemic hemostasis.
-
6.
Effect of Erythropoietin on Transfusion Requirements for Craniosynostosis Surgery in Children
Aljaaly HA, Aldekhayel SA, Diaz-Abele J, Karunanayka M, Gilardino MS
The Journal of Craniofacial Surgery. 2017;28((5):):1315-1319
Abstract
BACKGROUND Pediatric craniosynostosis surgery is associated with significant blood loss often requiring allogenic blood transfusion (ABT). This study explores the clinical effectiveness of preoperative erythropoietin (EPO) administration in pediatric craniosynostosis surgery in reducing transfusion requirements. METHODS A systematic review and meta-analysis of the literature was performed for studies published in English language between 1946 and 2015. Inclusion criteria included original studies in the pediatric population (0-8 years of age) involving preoperative use of EPO in craniofacial procedures with quantitative reporting of perioperative blood transfusion. Extracted data included demographics, hematocrit, hemoglobin, estimated blood loss, number of patients transfused, and amount of ABT. RESULTS Four studies met the inclusion criteria with a total of 117 patients. Patients were divided into 2 groups: EPO versus control. No statistical differences were found in the demographics between the 2 groups. Mean preoperative hematocrit level was higher in the EPO group compared with control (43% vs 35%). The percentage of patients who required ABT and the volume of transfused blood were less in the EPO group (54% vs 98% and 84 vs 283 mL, respectively). Meta-analysis of 3 comparable studies showed a lower proportion of patients who needed blood transfusion in the EPO group. CONCLUSIONS The present meta-analysis demonstrated that preoperative administration of EPO in pediatric craniosynostosis surgery decreased the proportion of patients requiring ABT. In addition, the volume of transfusion was reduced in patients who received EPO. Future randomized studies are needed to establish the cost-effectiveness of routine preoperative EPO administration in craniosynostosis surgery.
-
7.
Effectiveness of tranexamic acid for reducing intraoperative bleeding in palatoplasties: a randomized clinical trial
Arantes GC, Pereira RM, de Melo DB, Alonso N, Duarte MD
Journal of Cranio-Maxillo-Facial Surgery : Official Publication of the European Association for Cranio-Maxillo-Facial Surgery. 2017;45((5):):642-648
Abstract
BACKGROUND Few data are available regarding blood loss during cleft palate surgery. This study assessed the effect of using tranexamic acid in the reduction of intraoperative bleeding. METHODS A double-blind, randomized clinical trial compared intraoperative bleeding and the incidence of oronasal fistulas after palatoplasties in a control group that was given placebo and an intervention group that was given 10 mg/kg tranexamic acid followed by a continuous infusion of 1 mg/kg/h of the same until the end of surgery. Patients who underwent primary palatoplasty with no known or suspected coagulation disorders at our institution during the study period were included in the study. RESULTS 70 patients were allocated, 66 received the intervention. Blood loss was reduced by 11.9%, without statistical significance. The incidence of fistulas in the intervention and control groups was 12.9% and 18.75%, respectively. The reduction of 5.8% (CI 95%: 12%-23.8%) was not significant. CONCLUSIONS The reduction of intraoperative blood loss was lower than expected and not statistically significant; a larger sample is needed to confirm the observed reduction. The drug did not seem to have negative effects on flap viability.
-
8.
Systematic review of interventions for minimizing perioperative blood transfusion for surgery for craniosynostosis
White N, Bayliss S, Moore D
Journal of Craniofacial Surgery. 2015;26((1):):26-36.
Abstract
BACKGROUND Surgery for craniosynostosis is associated with the potential for significant blood loss. Multiple technologies have been introduced to reduce the volume of blood transfused. These are preoperative autologous donation; preoperative erythropoietin; intraoperative cell salvage (CS); acute normovolemic hemodilution; antifibrinolytic drugs such as tranexamic acid, -aminocaproic acid, and aprotinin; fibrin sealants or fibrin glue; and postoperative drain reinfusion. METHODS All comparative studies with a treatment group and a control group were considered. There was a range of different study types from randomized controlled trials to case series with historic controls. These were intervention versus no intervention or a comparison of 2 interventions. Studies were identified by searching Cochrane CENTRAL, MEDLINE, and EMBASE; manufacturer's Web sites; and bibliographies of relevant published articles. The primary outcome measures were the number of allogeneic blood donor exposures, the volume of allogeneic blood transfused, and the postoperative hemoglobin or hematocrit levels. RESULTS A total of 696 studies were identified. After removal of duplicates and after exclusion criteria were applied, there were 18 studies to be included. Fourteen were case series with controls and 4 were randomized controlled trials. CONCLUSIONS The production of high-quality evidence on the interventions to minimize blood loss and transfusion in children undergoing surgery for craniosynostosis is difficult. Most of the literature is nonrandomized and noncomparative. Several areas remain unaddressed. Erythropoietin and tranexamic acid are comparatively well studied; CS, acute normovolemic hemodilution, and aprotinin are less so. There is only 1 comparative study on the use of fibrin glue and drain reinfusion, with no studies on preoperative autologous donation and [Latin Small Letter Open E]-aminocaproic acid. Tranexamic acid is clinically effective in reducing allogeneic blood transfusion. There is some evidence that CS and erythropoietin may be clinically effective. None of the interventions studied are shown to be cost-effective because of lack of evidence.
-
9.
Evaluation of the efficacy of tranexamic acid on the surgical field in primary cleft palate surgery on children : a prospective, randomized clinical study
Durga P, Raavula P, Gurajala I, Gunnam P, Veerabathula P, Reddy M, Upputuri O, Ramachandran G
Cleft Palate-Craniofacial Journal. 2015;52((5)):e183-7.
Abstract
OBJECTIVE To assess the effect of tranexamic acid on the quality of the surgical field. DESIGN Prospective, randomized, double-blind study. SETTING Institutional, tertiary referral hospital. PARTICIPANTS American Society of Anesthesiologists physical status class I patients, aged 8 to 60 months with Group II or III (Balakrishnan's classification) clefts scheduled for cleft palate repair. INTERVENTIONS Children were randomized into two groups. The control group received saline, and the tranexamic acid group received tranexamic acid 10 mg/kg as a bolus, 15 minutes before incision. MAIN OUTCOME MEASURES Grade of surgical field on a 10-point scale, surgeon satisfaction, and primary hemorrhage. RESULTS Significant improvements were noted in surgeon satisfaction and median grade of assessment of the surgical field (4 [interquartile range, 4 to 6] in the control group vs. 3 [interquartile range, 2 to 4] in the test group; P = .003) in the tranexamic acid group compared to the control group. CONCLUSION Preincision administration of 10 mg/kg of tranexamic acid significantly improved the surgical field during cleft palate repair.
-
10.
Impact of supplemental vitamin k1 administration on postoperative blood component requirements after craniosynostosis repair: a prospective, placebo-controlled, randomized, blinded study
Kicker JS, Willson DF, Kelly RL, Jane JA Jr, Roberts SE, Conaway MR
Journal of Craniofacial Surgery. 2014;25((1):):154-9.
Abstract
Total cranial vault craniosynostosis repairs often require additional blood transfusions in the intensive care unit. Vitamin K1 participates in hepatic production of procoagulant proteins, and body stores of vitamin K1 are limited and dietary dependent. Surgical stress and diet interference may place infants at risk for vitamin K deficiency. Through design of a surgically stratified, randomized, placebo-controlled, blinded pilot study, we evaluated impact of vitamin K1 supplementation on coagulation parameters in infants after craniosynostosis repair. Patients received intramuscular vitamin K1 or placebo coincident with surgical incision. Serum vitamin K1 levels, protein induced in vitamin K absence-prothrombin, and factor VII were obtained at predetermined intervals after surgery. Patients received blood products in the intensive care unit in accordance with transfusion thresholds. Fifteen patients (vitamin K1 = 6, placebo = 9) completed the study procedures. Despite group assignment, patients received an average of 3 postoperative transfusions. Variations were observed with respect to intraoperative resuscitation of patients between comparably trained pediatric anesthesiologists. Thirty-three percent of patients were vitamin K1 deficient on 1 or more laboratory specimens. All breast-fed patients became deficient. Compared with placebo, elevated serum vitamin K1 levels at 6, 12, and 24 hours in the active drug group (P < 0.0001) were not associated with increased factor VII levels or reduced need for postoperative blood products. However, lack of a standardized intraoperative resuscitation plan may contribute to postoperative coagulopathy and is a major study limitation.