Incidence and risk factors of adverse events in pediatric hemato-oncological patients: A cohort study.

BACKGROUND: Pediatric hemato-oncological (HO) patients are highly susceptible to the occurrence of adverse events (AE), nevertheless few research has been done in this field. Our aim was to describe the incidence, type, severity and preventability of AE in these patients, including bone marrow transplant (BMT) patients, and to identify patient's risk factors for having an AE. METHODS: Retrospective cohort study. Children under 18yo hospitalized at the HO or BMT ward in 2016 were eligible for the study. Type of AE, severity and preventability were described as absolute and relative frequencies. Cumulative incidence of patients with at least one AE (CI_AE) and the rate of occurrence of all AE were calculated. Risk factors (sex, recovery probability, comorbidities and being a BMT patient) were analyzed using logistic regression. RESULTS: 114 patients were included, 58% were male, average age was 8.7yo and 25 were BMT patients. 44 had at least one AE, with CI_AE of 38.6% (95%CI 29.7-47.5). Overall rate of occurrence of AE was 2.5 cases per 100 patients-day (95%CI 2.15-2.98). For BMT and non-BMT patients they were 2.8 (95%CI 2.2-3.6) and 2.5 (95%CI 1.98-3.1) respectively. Healthcare related infection was the most frequent AE. Most AE were moderate and with high preventability. Being a BMT patient was the only independent factor associated with the occurrence of at least one AE (OR=11.5, p<0.001). CONCLUSIONS: Our findings suggest that AE tend to be moderate and preventable in HO pediatric patients. BMT patients seem to be at greater risk of having an AE. Strategies focused on patient safety need to account for their specific characteristics.

Common variants of catechol-O-methyltransferase influence patient-controlled analgesia usage and postoperative pain in patients undergoing total hysterectomy.

Catechol-O-methyltransferase (COMT) gene polymorphisms and haplotypes have been associated with both experimental and clinical pain phenotypes. In this prospective study, we investigated the association of three common polymorphisms with experimentally induced pressure pain, postoperative pain and amount of self-administered morphine in 973 patients who underwent scheduled total hysterectomy. DNA extracted from peripheral blood was genotyped for three COMT polymorphisms by Taqman assay or a PCR-based method. In the overall sample, rs4633 and rs4680 were significantly associated with morphine use, whereas rs4818 was associated with time-averaged pain scores. Statistically significant associations were found between COMT rs4633 and rs4680 genotypes and the amount of morphine self-administered through a patient-controlled analgesia pump. For rs4818, the only statistically significant association was with time-averaged pain scores. Haplotype analysis showed statistically significant association of the low pain sensitivity haplotype with time-averaged pain scores; and average pain sensitivity haplotype with total morphine and weight-adjusted morphine.

A randomised comparison of variable-frequency automated mandatory boluses with a basal infusion for patient-controlled epidural analgesia during labour and delivery.

This trial was conducted to compare the analgesic efficacy of administering variable-frequency automated boluses at a rate proportional to the patient's needs with fixed continuous basal infusion in patient-controlled epidural analgesia (PCEA) during labour and delivery. We recruited a total of 102 parturients in labour who were randomly assigned to receive either a novel PCEA with automated mandatory boluses of 5 ml administered once, twice, three or four times per hour depending on the history of the parturient's analgesic demands over the past hour (Automated bolus group), or a conventional PCEA with a basal infusion of 5 ml.h(-1) (Infusion group). The incidence of breakthrough pain requiring supplementation by an anaesthetist was significantly lower in the Automated bolus group, three out of 51 (5.9%) compared with the Infusion group, 12 out of 51 (23.5%, p = 0.023). The time-weighted mean (SD) hourly consumption of ropivacaine was similar in both groups, 10.0 (3.0) mg in the Automated bolus group vs 11.1 (3.2) mg in the Infusion group (p = 0.06). Parturients from the Automated bolus group reported higher satisfaction scores compared with those in the Infusion group, 96.5 (5.0) vs 89.2 (9.4), respectively (p < 0.001). There was no difference in the incidence of maternal side-effects and obstetric and neonatal outcomes.

A randomized comparison of automated intermittent mandatory boluses with a basal infusion in combination with patient-controlled epidural analgesia for labor and delivery.

BACKGROUND: Automated mandatory boluses (AMB), when used in place of a continuous basal infusion, have been shown to reduce overall local anesthetic consumption without compromising analgesic efficacy in patient-controlled epidural analgesia (PCEA). We hypothesized that our PCEA+AMB regimen could result in a reduction of breakthrough pain requiring epidural supplementation in comparison with PCEA with a basal infusion (PCEA+BI). METHODS: We recruited sixty-two healthy ASA I nulliparous parturients in early labor. The parturients were randomized to receive 0.1% ropivacaine+fentanyl 2 µg/mL either via PCEA+BI (PCEA with basal continuous infusion of 5mL/h) or PCEA+AMB (PCEA with AMB of 5 mL every hour instead of a basal infusion) immediately following successful induction of combined spinal-epidural (CSE) analgesia. Block characteristics, incidence of breakthrough pain requiring epidural supplementation, side effects, obstetric outcomes, Apgar scores and overall maternal satisfaction with analgesia were noted. RESULTS: The time-weighted hourly consumption of ropivacaine (PCEA and clinician supplementation for breakthrough pain) was significantly lower in the PCEA+AMB group (mean=7.6 mL, SD 3.2) compared to the PCEA+BI group (mean=9.3 mL, SD 2.5; P<0.001). The mean time to first PCEA self-bolus following CSE was significantly longer in the PCEA+AMB group compared to the PCEA+BI group (268 min vs. 104 min; P<0.001). Parturients in Group PCEA+AMB also gave higher satisfaction scores. The incidence of breakthrough pain was similar in both groups. CONCLUSION: PCEA+AMB, when compared to PCEA+BI, confers greater patient satisfaction and a longer duration of effective analgesia after CSE despite reduced analgesic consumption.

Comparison of automated intermittent low volume bolus with continuous infusion for labour epidural analgesia.

Delivery of local anaesthetics via automated intermittent bolus has been shown to improve epidural analgesia compared to delivery via continuous epidural infusion. However the optimal bolus volume has not been investigated. This randomised, double-blind study compared the analgesic efficacy of automated intermittent bolus (volume 2.5 ml every 15 minutes) with that of a continuous epidural infusion (10 ml/hour) for the maintenance of labour epidural analgesia, to determine whether the advantages previously demonstrated for automated intermittent bolus over continuous epidural infusion are retained at this low bolus volume. With the approval of the Hospital Ethics Committee, we recruited 50 parturients who received combined spinal epidural analgesia with intrathecal ropivacaine 2 mg and fentanyl 15 microg. For epidural maintenance, participants were randomised to either the automated intermittent bolus group (2.5 ml automated intermittent epidural boluses of ropivacaine 0.1% plus fentanyl 2 microg/ml delivered over a two-minute period every 15 minutes) or the continuous epidural infusion group (continuous epidural infusion of ropivacaine 0.1% plus fentanyl 2 microg/ml at 10 ml/hour). The primary study outcome was the incidence of pain during labour that required management with supplemental epidural analgesia. There were no significant differences between the two regimens in terms of breakthrough pain (automated intermittent bolus 36% [9/25] vs continuous epidural infusion 32% [8/25], P = 0.77). At the doses used in this study, maintenance of labour analgesia using automated intermittent bolus at a bolus volume of 2.5 ml every 15 minutes does not decrease the incidence of breakthrough pain or improve analgesic efficacy compared to continuous epidural infusion.

Computer-integrated patient-controlled epidural analgesia: a preliminary study on a novel approach of providing pain relief in labour.

INTRODUCTION: The need for individualisation of analgesic therapy in labour cannot be overemphasised. We have devised a programme, based on a novel clinical algorithm, that converts a continuous infusion pump into a patient-controlled epidural analgesia (PCEA) pump that is responsive to the patient's needs by varying its rate of infusion. METHODS: In this double-blinded, controlled trial, 40 American Society of Anesthesiologists 1 patients were recruited to receive either a continuous infusion of 10 ml/hour (Continuous Epidural Infusion [CEI], n=20) or the computer-integrated (CI) regimen (CI-PCEA, n=20) to maintain epidural analgesia after successful induction of combined spinal analgesia during early labour. The proportion of patients who had delivered without a requirement for analgesic supplementation was the primary outcome measure. RESULTS: There was a significant difference in the incidence of breakthrough pain, i.e. the primary outcome measure (two in CI-PCEA versus eight in the CEI group, p-value is 0.027). There was a trend towards a longer duration before analgesic supplementation of analgesia was required after its induction with CI-PCEA than CEI (p-value is 0.06). We could not detect a difference in the total hourly consumption of epidural analgesics between the two groups. CONCLUSION: Our study also showed that with the CI-PCEA programme, we were able to convert an ordinary infusion pump to one which analyses the patients' needs in the previous hour (based on analgesic demands) and automatically adjusts the basal infusion accordingly. CI-PCEA reduced the incidence of breakthrough pain without the evidence of increasing drug consumption when compared with CEI.

Comparison of computer integrated patient controlled epidural analgesia vs. conventional patient controlled epidural analgesia for pain relief in labour.

Computer integrated-patient controlled epidural analgesia (CI-PCEA) is a novel drug delivery system. It automatically titrates the background infusion rate based on the individual parturient's need. In this randomised trial, we compared the local anaesthetic consumption by parturients using CI-PCEA with demand only patient controlled epidural analgesia (PCEA) for labour analgesia. We recruited 40 parturients after approval by the ethics committee. Group PCEA (n = 20) received demand only PCEA. Group CI-PCEA (n = 20) received a similar PCEA regimen but the computer integration titrated the background infusion to 5, 10 or 15 ml x h(-1) if the patient required one, two or three demand boluses, respectively, in the previous hour. The background infusion decreased by 5 ml x h(-1) if there was no demand bolus in the previous hour. The sample size was calculated to show equivalence in local anaesthetic used. The time weighted consumption of local anaesthetic was similar in both groups (mean difference 0.7 mg x h(-1), 95% confidence interval [CI: -2.5, 1.1]; p = 0.425). The CI-PCEA group had higher maternal satisfaction scores: mean (SD) 93 (7) vs. 86 (11), p = 0.042. CI-PCEA does not increase the use of local anaesthetic when compared with demand only PCEA but does increase patient satisfaction.

Neuraxial block for labour analgesia--is the combined spinal epidural (CSE) modality a good alternative to conventional epidural analgesia?

AIM: Apart from conventional epidural analgesia (EA), the combined spinal-epidural (CSE) modality is fast becoming a popular technique for treating labour pain. In this study, we investigated the differences in the patient profile and outcome between CSE and EA for labour pain in KK Women's and Children's Hospital. METHODOLOGY: Data pertaining to 1,532 healthy parturients who had received either CSE or EA for labour pain during a six-month period was systematically collected by using a specially designed form. Multiple logistic regression analysis was used to determine the independent predictors of patient satisfaction and the relation of parturient factors on the choice of block. The side effects and the outcome of labour were also compared. RESULTS: CSE accounted for 80% of all neuraxial blocks performed for labour analgesia (vs 20% for EA). Anaesthesiologists were more inclined to using CSE than EA for multiparous parturients (OR 2.03, p<0.01) in a more painful (OR=1.61, p=0.03) and advanced stage of labour (OR=1.12, p=0.03). The need for supplemental analgesics was greater for EA (p<0.01). Patient satisfaction was higher for CSE (OR=1.77, p<0.026). CSE had a higher risk of pruritus (29% vs 14%, p<0.01) but lower risk of post block neural deficits (0% vs 2%, p<0.01) than EA. No difference in the mode of delivery was detected between the two groups. CONCLUSION: CSE is a safe and good alternative to EA as a technique of neuraxial block for labour analgesia.

Parturient-controlled epidural analgesia during labour: bupivacaine vs. ropivacaine.

In this randomised, controlled study, we compared the hourly dose requirement of ropivacaine 0.125% (group R, n = 16) with bupivacaine 0.125% (group B, n = 16) provided by demand-only (bolus 5 ml, lockout 10 min) parturient-controlled epidural analgesia during labour. The hourly dose requirement was comparable although group R had a lower successful to total demands ratio (p < 0.05). We also found that both groups were clinically indistinguishable in terms of pain relief and side-effects. No difference in maternal or fetal outcome was detected. We conclude that, at a concentration of 0.125%, ropivacaine and bupivacaine were equally effective when self-administered using this patient-controlled regimen.