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.
Is fresh, leucodepleted, whole blood transfusion superior to blood component transfusion in pediatric patients undergoing spinal deformity surgeries? A prospective, randomized study analyzing postoperative serological parameters and clinical recovery
European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2021;:1-7
PURPOSE To compare the effectiveness of fresh whole blood (FWB) and blood component transfusion in improving clinical outcome and serological parameters in the early postoperative period following spinal deformity surgery. METHODS Patients undergoing major spinal deformity surgeries involving ≥ 6 levels of fusion and expected blood loss ≥ 750 ml between September 2017 and August 2018 were included in the study. The patients were randomized into two groups: FWBG and CG, receiving fresh whole blood and component transfusions, respectively. RESULTS A total of 65 patients with spinal deformities of different etiologies were included. The mean age was 14.0 and 14.9 years in FWB and CG, respectively. All other preoperative parameters were comparable. The mean fusion levels and surgical time were 11.1 and 221.20 min in FWB, as compared with 10.70 and 208.74minutes in CG, respectively. Intraoperative blood losses were 929 ml (FWBG) and 847 ml(CG), and the mean volumes of transfusion were 1.90 (FWBG) and 1.65 units (CG). FWBG was significantly superior to CG in the following clinical and laboratory parameters: duration of oxygen dependence [36.43 (FWBG) vs. 43.45 h (CG); P = 0.0256], mean arterial pH [7.442 (FWBG) vs. 7.394 (CG); p < 0.001], interleukin-6 [30.04 (FWBG) vs. 35.10 (CG); p < 0.019], mean duration of HDU stay [40.6 hours (FWBG) vs 46.51 hours (CG); p = 0.0234] and postoperative facial puffiness [7/30 in FWBG vs. 18/35 (CG) (P < 0.02)]. CONCLUSION FWB transfusion can potentially improve the immediate postoperative outcome in patients undergoing major spinal deformity surgeries by reducing the duration of intensive care unit stay and oxygen dependence. The other potential benefits of this practice, based on our study, include a reduced inflammatory response (reduced lactate and IL-6) and postoperative facial puffiness. However, further large-scale validation studies in future are necessary to precisely determine the role of FWB in spine surgeries. LEVEL OF EVIDENCE II Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.
Paediatric patients undergoing spinal deformity surgery (n= 65).
Fresh whole blood: FWBG group (n= 30).
Component transfusions: CG group (n = 35).
The mean fusion levels and surgical time were 11.1 and 221.20 min in FWB, as compared with 10.70 and 208.74 minutes in CG, respectively. Intraoperative blood losses were 929 ml (FWBG) and 847 ml (CG), and the mean volumes of transfusion were 1.90 (FWBG) and 1.65 units (CG). FWBG was significantly superior to CG in the following clinical and laboratory parameters: duration of oxygen dependence, mean arterial pH, interleukin-6, mean duration of high dependency unit stay and postoperative facial puffiness.
Autologous platelet gel improves outcomes in tubularized incised plate repair of hypospadias
Journal of pediatric surgery. 2021
BACKGROUND hypospadias is one of the most widespread male congenital anomalies, occurring in 1:250 to 1:300 live births. Several repair techniques have been developing to improve the outcomes. PURPOSE a randomized prospective controlled study was adopted to evaluate effectiveness of autologous platelet gel in healing promotion and improving the outcomes of hypospadias repair. METHODS thirty children who aged between 6 months and 12 years were recruited and subdivided into two groups; group A had tubularized incised plate (TIP) repair with autologous platelet gel application and group B had TIP repair without autologous platelet gel. RESULTS there was no significant difference in duration of operation between both groups. All patients in groups A and B had slit-like meatus shape in the distal glans. While all those of group A had one urine stream, yet only 11 of group B had one. There were complications that happened exclusively in group B such as spray stream (27%) and fistula (20%). Whereas other complications occurred insignificantly more in group B than in A including meatal stenosis (53 versus 27%), glans dehiscence, (20 versus 7%), bleeding (33 versus 13%), infection (33 versus 27%), edema (27% versus13), respectively. The incidence of skin necrosis was equal in both groups. CONCLUSION autologous platelet gel usage in TIP hypospadias repair can be a reliable technique to promote wound healing, and to limit of postoperative surgical complications.
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.
Does a balanced colloid decrease perioperative blood loss in paediatric cardiac surgery: A double-blinded randomized controlled trial?
European journal of anaesthesiology. 2021
BACKGROUND Unbalanced fluid solutions cause metabolic acidosis and could be associated with impaired coagulation and increased blood loss. OBJECTIVE To investigate whether the use of a balanced colloid compared with a saline colloid for peri-operative fluid therapy in children undergoing cardiac surgery is associated with decreased blood loss and exposure to blood products. DESIGN Double-blinded randomised controlled trial. SETTING Tertiary children's hospital from 2013 to 2016. PATIENTS Children older than 29 days and younger than 3 years admitted for cardiac surgery with cardiopulmonary bypass (CPB). Exclusion criteria were emergency cardiac surgery, moribund (American Society of Anesthesiologists 5), Jehovah's witnesses, coagulopathy, renal failure, liver injury, intracranial haemorrhage and electrolyte disturbances. From the 128 patients eligible, 88 were included in the study. INTERVENTION Random assignment of patients to either a saline colloid (6% hydroxyethyl starch 130/0.4 in 0.9% NaCl) or a balanced-electrolyte colloid (6% hydroxyethyl starch 130/0.4 in an isotonic solution) for CPB priming and intra- and postoperative fluid therapy during the first postoperative 48 h. MAIN OUTCOME MEASURE The primary outcome measure was calculated blood loss until the third postoperative day (POD3). RESULTS A total of 44 patients were included in each study arm. Calculated blood loss at POD3 was not significantly different between the groups (saline colloid 19.9 [IQR 13.8 to 26.1] ml kg-1 versus balanced colloid 15.9 [IQR 9.0 to 25.3 ml kg-1], P = 0.409). Secondary outcomes related to bleeding, exposure to blood products and coagulation were not different between groups. There was also no difference in length of mechanical ventilation, intensive care and hospital length of stay between groups. CONCLUSION The use of a balanced colloid for peri-operative fluid therapy compared with a saline one is not associated with decreased blood loss or exposure to blood products. TRIAL REGISTRATION EudraCT identifier: 2012-006034-17 and ClinicalTrial.gov identifier: NCT02584868.
Comparison between intraoperative bleeding score and ROTEM® measurements to assess coagulopathy during major pediatric surgery
Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis. 2021;:103191
PURPOSE Intraoperative bleeding should be regularly assessed visually to guide coagulation management. Whereas viscoelastic testing with ROTEM® measurement has been proven to be useful in detecting coagulopathies, the visual assessment is not standardized. This study therefore aims to compare a standardized visual assessment with ROTEM® results. METHODS A 5-point bleeding score was created and applied in a recently published randomized controlled trial in major pediatric non-cardiac surgery. This score assesses overall bleeding tendency and the occurrence of diffuse bleeding, aqueous bleeding, bleeding outside the operative field, and the ability to control bleeding. Validity of this score was tested by post hoc comparison to the results of simultaneously performed ROTEM® measurements. RESULTS Signs of coagulopathic bleeding were assessed at 183 time points. Mild to moderate bleeding intensity was judged at 103 time points, in 42 % abnormal ROTEM® traces were obtained simultaneously. When severe bleeding was scored, abnormal ROTEM values occurred in 58 %, and FIBTEM-values were significantly lower than in the "no bleeding group". Altogether, the correlation between bleeding score and ROTEM® measurements was not significant. CONCLUSIONS The standardized visual assessment did not correlate well with ROTEM® measurements, suggesting that it is not useful to detect coagulopathy. Trial registry number: ClinicalTrials.gov identifier No. NCT01487837.
Ultrasonic Bone Scalpel (USBS) Does Not Reduce Blood Loss During Posterior Spinal Fusion (PSF) in Patients with Adolescent Idiopathic Scoliosis (AIS): Randomized Clinical Trial
STUDY DESIGN Randomized Clinical Trial. OBJECTIVE The aim of this study was to compare the efficacy of USBS with standard-of-care surgical instruments during posterior spinal fusion (PSF) in patients with adolescent idiopathic scoliosis (AIS) by evaluating the difference in estimated blood loss per level fused (EBL/level). SUMMARY OF BACKGROUND DATA PSF surgery for AIS is often associated with high blood loss. Use of an ultrasonic bone scalpel (USBS) has been proposed to reduce blood loss during scoliosis surgery. METHODS This was a single-blinded (patient-blinded), randomized, controlled superiority trial. We randomized 66 patients with AIS undergoing PSF to the control group (osteotome) or the experimental group (USBS). The primary outcome was intraoperative EBL/level obtained from red blood cell salvage reports. One-year follow-up was available for 57 of 62 (92%) of patients. RESULTS EBL/level averaged 35 and 39 mL/level in the experimental and control groups, respectively [adjusted mean difference USBS - osteotome -8 mL/level, 95% CI: -16.4 to 0.3 mL/level, P = 0.0575]. There was no difference in curve correction [adjusted mean difference: -1.7%, 95% CI: -7.0 to 3.6%, P = 0.5321] or operative time [adjusted mean difference: -3.55 minutes, 95% CI: -22.45 to 15.46 min, P = 0.7089] between groups. Complications requiring change in routine postoperative care were noted in eight patients: two occurred in patients assigned to the experimental group and six occurred in patients assigned to the control group. CONCLUSION There was no clinically significant difference in total blood loss, EBL/level, or complications between the two groups. In contrast to reports from other centers, at our high-volume spine center, USBS did not lead to reduced blood loss during PSF for AIS. These results may not be generalizable to centers with longer baseline operative times or higher baseline average blood loss during PSF for AIS.Level of Evidence: 1.
Timing of temporizing neurosurgical treatment in relation to shunting and neurodevelopmental outcomes in post-hemorrhagic ventricular dilatation of prematurity: a meta-analysis
The Journal of pediatrics. 2021
OBJECTIVE To determine the relationship between timing of initiation of temporizing neurosurgical treatment and rates of ventriculoperitoneal shunting (VPS) and neurodevelopmental impairment in premature infants with post-hemorrhagic ventricular dilatation (PHVD). STUDY DESIGN We searched MEDLINE, EMBASE, CINAHL, Web of Science, Cochrane Database of Systematic Reviews, and Cochrane Center Register of Controlled Trials for studies that reported on premature infants with PHVD who received TNP. Timing of TNP, gestational age, birth weight, and outcomes of conversion to VPS, moderate-to-severe NDI, infection, TNP revision, and death at discharge were extracted. RESULTS Sixty-two full-length articles and six conference abstracts (n=2533 patients) published through November 2020 were included. Pooled rate for conversion to VPS was 60.5% (95% CI=54.9-65.8), moderate-severe NDI 34.8% (95% CI=27.4-42.9), infection 8.2% (95% CI=6.7-10.1), revision 14.6% (95% CI=10.4-20.1), and death 12.9% (95% CI=10.2-16.4). Average age at TNP was 24.2+/-11.3 days. On meta-regression, older age at TNP was a predictor of conversion to VPS (p<0.001) and NDI (p<0.01). Later year of publication predicted increased survival (p<0.01) and external ventricular drains were associated with more revisions (p=0.001). Tests for heterogeneity reached significance for all outcomes and qualitative review showed heterogeneity in study inclusion and diagnosis criteria for PHVD and initiation of TNP. CONCLUSIONS Later timing of TNP predicted higher rates of conversion to VPS and moderate-severe NDI. Outcomes were often reported relative to number of patients who received TNP and criteria for study inclusion and initiation of TNP varied across institutions. There is need for more comprehensive outcome reporting that includes all infants with PHVD regardless of treatment.
The Efficacy and Safety of Epsilon-Aminocaproic Acid for Perioperative Blood Management in Spinal Fusion Surgery: A systematic review and meta-analysis
World neurosurgery. 2021
BACKGROUND Perioperative blood loss is a major concern in spinal fusion surgery, which often requires blood transfusion. A large amount of perioperative blood loss might increase the risks of various perioperative complications. Recently, there has been a series of clinical studies focusing on the perioperative administration of epsilon-aminocaproic acid (EACA) in spinal fusion surgery. The aim of this review was to evaluate the efficacy and safety of EACA in spinal fusion surgery. METHODS We systematically searched electronic databases (MEDLINE, EMBASE, PubMed, and Cochrane Central Register of Controlled Trials) up to April 2021. The perioperative blood loss, blood transfusion and complication data were extracted and analysed by RevMan Manager 5.3. RESULTS Finally, six randomized controlled studies, involving 398 patients undergoing spinal fusion surgery, were enrolled in this systematic review. Compared with the blank control group, the EACA group had significantly lower total perioperative blood loss, postoperative blood loss, postoperative hemoglobin, postoperative blood transfusion units, total blood transfusion units, and postoperative red blood cell transfusion units. Additionally, no significant differences were observed between the EACA group and control group in intraoperative blood loss, intraoperative blood transfusion units, intraoperative crystalloid administered, hospital stays, operative time, perioperative respiratory complications, and wound bleeding. CONCLUSIONS EACA in patients undergoing spinal fusion surgery is effective in perioperative hemostasis without increasing the incidence of postoperative complications. However, the long-term adverse side of EACA in spinal fusion surgery still need more large-scale trials.
Antifibrinolytic Drugs for the Prevention of Bleeding in Pediatric Cardiac Surgery on Cardiopulmonary Bypass: A Systematic Review and Meta-analysis
Anesthesia and analgesia. 2021
BACKGROUND Bleeding is one of the commonest complications affecting children undergoing cardiac surgery on cardiopulmonary bypass. Antifibrinolytic drugs are part of a multifaceted approach aimed at reducing bleeding, though sufficiently sized pediatric studies are sparse, and dosing algorithms are heterogeneous. Our objective was to evaluate the efficacy and safety of antifibrinolytic agents as well as the effectiveness of different dosing regimens in pediatric cardiac surgery using cardiopulmonary bypass. METHODS We performed a systematic review and meta-analysis evaluating randomized controlled trials published between 1980 and 2019, identified by searching the databases MEDLINE, EMBASE, PubMed, and CENTRAL. All studies investigating patients <18 years of age without underlying hematological disorders were included. The primary outcome was postoperative bleeding; secondary end points included blood product transfusion, mortality, and safety (thromboses, anaphylaxis, renal or neurological dysfunction, and seizures). Different dosing regimens were compared. Studies were dual appraised, outcomes were reported descriptively and, if appropriate, quantitatively using the Review Manager 5 (REVMAN 5) software (The Cochrane Collaboration). RESULTS Thirty of 209 articles were included, evaluating the following drugs versus control: aprotinin n = 14, tranexamic acid (TXA) n = 12, and epsilon-aminocaproic acid (EACA) n = 4. The number of participants per intervention group ranged from 11 to 100 (median, 25; interquartile range [IQR], 20.5) with a wide age span (mean, 13 days to 5.8 years) and weight range (mean, 3.1-26.3 kg). Methodological quality was low to moderate.All agents reduced mean 24-hour blood loss compared to control: aprotinin by 6.0 mL/kg (95% confidence interval [CI], -9.1 to -3.0; P = .0001), TXA by 9.0 mL/kg (95% CI, -11.3 to -6.8; P < .00001), and EACA by 10.5 mL/kg (95% CI, -21.1 to 0.0; P = .05). Heterogeneity was low for TXA (I2 = 29%; P = .19), moderate for aprotinin (I2 = 41%; P = .11), and high for EACA (I2 = 95%; P = <.00001). All agents also reduced 24-hour blood product transfusion. There was no clear dose-response effect for TXA nor aprotinin. Studies were underpowered to detect significant differences in mortality, thromboses, anaphylaxis, and renal or neurological dysfunction. CONCLUSIONS The available data demonstrate efficacy for all 3 antifibrinolytic drugs. Therefore, the agent with the most favorable safety profile should be used. As sufficient data are lacking, large comparative trials are warranted to assess the relative safety and appropriate dosing regimens in pediatrics.