Implementing PDSA Methodology for Pediatric Appendicitis Increases Care Value for a Tertiary Children's Hospital.

INTRODUCTION: We used the plan-do-study-act (PDSA) framework to develop and implement an evidence-based clinical practice guideline (CPG) within an urban, tertiary children's referral center. METHODS: We developed an evidence-based CPG for appendicitis using iterative PDSA cycles. Similar CPGs from other centers were reviewed and modified for local implementation. Adjuncts included guideline-specific order sets and operative notes in the electronic medical record system. Outcomes included length of stay (LOS), 30-day readmissions, hospital costs, and patient and family experience (PFE) scores. Our team tracked outcome, process, and balancing measures using Statistical Process Charts. Outcome measures were compared over 2 fiscal quarters preimplementation and 3 fiscal quarters postimplementation, using interrupted time series, student t test, and chi-square tests when appropriate. RESULTS: LOS for simple (uncomplicated) appendicitis decreased to 0.87 days (interquartile range [IQR] 0.87-0.94 days) from 1.1 days (IQR 0.97-1.42 days). LOS for complicated appendicitis decreased to 4.96 days (IQR 4.95-6.15) from 5.58 days (IQR 5.16-6.09). This reduction equated to an average cost-savings of $1,122/patient. Thirty-day readmission rates have remained unchanged. PFE scores increased across all categories and have remained higher than national benchmarks. CONCLUSION: Development and Implementation of a CPG for pediatric appendicitis using the PDSA framework adds value to care provided within a large tertiary center.

Neuraxial Anesthesia in Children With Ventriculoperitoneal Shunts.

Neuraxial anesthesia has been demonstrated to be safe and effective for children undergoing subumbilical surgery. There is limited evidence regarding the safety of neuraxial anesthesia in pediatric patients with a ventriculoperitoneal shunt. We evaluated a series of 25 patients with indwelling ventriculoperitoneal shunts for complications within 30 days of any procedure performed with a neuraxial technique. One patient required a ventriculoperitoneal shunt revision 5 days after a lumbar catheter placement. The neurosurgeon determined the revision to be likely unrelated to the patient's lumbar catheter. Concerns about the use of neuraxial anesthesia in patients with an indwelling ventriculoperitoneal shunt may be overstated.

Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database.

BACKGROUND: The caudal block is the most commonly performed regional anesthesia technique in pediatric patients undergoing surgical procedures, but safety concerns raised by previous reports remain to be addressed. Our main objective in current investigation was to estimate the overall and specific incidence of complications associated with the performance of caudal block in children. METHODS: This was an observational study using the Pediatric Regional Anesthesia Network database. A complication after a caudal block was defined by the presence of at least 1 of the following: block failure, vascular puncture, intravascular test dose, dural puncture, seizure, cardiac arrest, sacral pain, or neurologic symptoms. In addition, if a complication was also coded, the presence of temporary or permanent sequelae was evaluated. Additional exploratory analyses were performed to identify patterns of local anesthetic dosage. RESULTS: Eighteen thousand six hundred-fifty children who received a caudal block were included in the study. The overall estimated incidence (95% confidence interval [CI]) of complications after caudal blocks was 1.9% (1.7%-2.1%). Patients who developed complications were younger, median (interquartile range) of 11 (5-24) months, compared to those who did not develop any complications, 14 (7-29) months, P = 0.001. The most common complications were block failure, blood aspiration, and intravascular injection. No cases of temporary or permanent sequelae were identified leading to an estimated incidence (95% CI) of 0.005% (- % to 0.03%). Four thousand four hundred-six of 17,867 (24.6%; 95% CI, 24%-25.2%) subjects received doses (>2 mg of bupivacaine equivalents/kg) that could be potentially unsafe. CONCLUSIONS: Safety concerns should not be a barrier to the use of caudal blocks in children assuming an appropriate selection of local anesthetic dosage.

Transversus abdominis plane block in children: a multicenter safety analysis of 1994 cases from the PRAN (Pediatric Regional Anesthesia Network) database.

BACKGROUND: Currently, there is not enough evidence to support the safety of the transversus abdominis plane (TAP) block when used to ameliorate postoperative pain in children. Safety concerns have been repeatedly mentioned as a major barrier to performing large randomized trials in children. The main objective of the current investigation was to determine the incidence of overall and specific complications resulting from the performance of the TAP block in children. In addition, we evaluated patterns of local anesthetic dosage selection in the same population. METHODS: This was an observational study using the Pediatric Regional Anesthesia Network database. A complication from the TAP block was defined by the presence of at least one of the following intraoperative and/or postoperative factors: puncture of the peritoneum or organs, vascular puncture, cardiovascular, pulmonary and/or neurological symptoms/signs, hematoma, and infection. Additional analyses were performed to identify patterns of local anesthetic dosage. RESULTS: One thousand nine hundred ninety-four children receiving a TAP block were included in the analysis. Only 2 complications were reported: a vascular aspiration of blood before local anesthetic injection and a peritoneal puncture resulting in an overall incidence of complications (95% CI) of 0.1% (0.02%-0.3%) and a specific incidence of complications (vascular aspiration or peritoneal puncture) of 0.05% (0.0054%-0.2000%). Neither of these complications resulted in additional interventions or sequelae. The median (95% range) for the local anesthetic dose per weight for bilateral TAP blocks was 1.0 (0.47-2.29) mg of bupivacaine equivalents per kilogram; however, subjects' weights were not sufficient to explain much of the variability in dose. One hundred thirty-five of 1944 (6.9%; 95% CI, 5.8%-8.1%) subjects received doses that could be potentially toxic. Subjects who received potentially toxic doses were younger than subjects who did not receive potentially toxic doses, 64 (19-100) months and 108 (45-158) months, respectively (P < 0.001). CONCLUSIONS: The upper incidence of overall complications associated with the TAP block in children was 0.3%. More important, complications were very minor and did not require any additional interventions. In contrast, the large variability of local anesthetic dosage used can not only minimize potential analgesic benefits of the TAP block but also result in local anesthetic toxicity. Safety concerns should not be a major barrier to performing randomized trials to test the efficacy of the TAP block in children as long as appropriate local anesthetic dose regimens are selected.

Pediatric pain management.

Regional anesthesia has become an integral part of adult anesthesia. Although not routinely used in children because of the need for general anesthesia that is necessary to keep the patients from moving and cooperating with the operator, regional anesthesia has been gaining immense popularity in the last decade. Although there is not much objective evidence, large prospective databases and expert opinion have favored administering regional anesthesia in the asleep child safely because major neural damage has not been reported in children. This review discusses a comprehensive approach to acute pain management in infants, children, and adolescents using regional anesthesia.

Parent-assisted or nurse-assisted epidural analgesia: is this feasible in pediatric patients?

AIM: The aim of this study was to assess the feasibility of parent-assisted or nurse-assisted epidural analgesia (PNEA) for control of postoperative pain in a pediatric surgical population. METHODS: After the institutional review board (IRB) approval was obtained, an analysis of our pain treatment services database of pediatric surgical patients with epidural catheters in whom the parent and/or nurse were empowered to activate the epidural demand-dose button was evaluated. RESULTS: Over a 10 -year period between 1999 and 2008, 128 procedures in 126 patients were provided parent or nurse assistance of the epidural demand dose. Satisfactory analgesia was obtained in 86% of patients with no or minor adjustments in PNEA parameters. Fourteen percent of patients were converted to intravenous patient-controlled analgesia (PCA) for inadequate analgesia (7%) or side effects (7%). None of the patients in this cohort required treatment for respiratory depression or excessive sedation. CONCLUSIONS: Parent-assisted or nurse-assisted epidural analgesia can be safely administered to children undergoing surgery who are physically or cognitively unable or unwilling to self-activate a demand dose. Additional studies are needed to compare the efficacy of PNEA with other modalities for postoperative pain control in children.

Herbal and homeopathic medication use in pediatric surgical patients.

BACKGROUND: Patients who present for surgery may be using herbal or homeopathic preparations; adverse effects of some of these substances include bleeding, cardiovascular changes, and liver dysfunction. Little information is available on the frequency of use in the pediatric surgical population. METHODS: With institutional approval, a survey was conducted to assess the use of vitamins, nutritional supplements, or herbal or homeopathic preparations in children presenting for surgery in five geographically diverse centers in the USA. RESULTS: A total of 894 completed surveys showed that overall, 3.5% of pediatric surgical patients had been given herbal or homeopathic medications in the 2 weeks prior to surgery. Most substances were prescribed by parents. The use of these medications did not differ between children with coexisting diseases and those without; use was also not different among ethnic groups or by residence setting (city, suburban, rural). There was a significant difference between the west coast centers in the study compared with the rest of the country (7.5% of patients in Palo Alto, CA; 5.5% of patients in Seattle, WA; 1.5% of patients in Chicago, IL; and 1.9% in Virginia and Delaware used herbal or homeopathic remedies). The most prevalent substance given to children presenting for elective surgery was Echinacea. CONCLUSIONS: Herbal and homeopathic medications are used by a small percentage of pediatric patients presenting for elective pediatric surgery patients. Use of these substances should be addressed in the preoperative history.

The addition of clonidine 2 microg.kg-1 does not enhance the postoperative analgesia of a caudal block using 0.125% bupivacaine and epinephrine 1:200,000 in children: a prospective, double-blind, randomized study.

BACKGROUND: In this prospective, randomized, double-blind study, we compared the efficacy of 0.125% bupivacaine and epinephrine 1:200,000 with and without clonidine 2 microg.kg-1 for 'single shot' pediatric caudal analgesia. METHODS: Thirty ASA I and II children, ages 2-8 years, undergoing outpatient surgical procedures below the umbilicus received 1 ml.kg-1 0.125% bupivacaine with fresh epinephrine 1:200,000 and clonidine 2 microg.kg-1 (group-C) or 1 ml.kg-1 0.125 % bupivacaine with epinephrine 1:200 000 (group-NC). All patients received a standardized general anesthetic (induction with 67% N2O in O2 and sevoflurane followed by isoflurane maintenance). Primary outcome measures were time to first rescue analgesic and number of patients requiring rescue analgesic at 4, 6, 8, 12, and 24 h after caudal placement. Secondary outcome measures included: extubation times, Objective Pain Scale (OPS) scores, sedation scores, time in postanesthesia care unit (PACU), discharge time, number of analgesic doses given in 24 h following caudal blockade, and adverse effects (vomiting, hypotension, and bradycardia). RESULTS: There were no differences in demographics, investigated parameters, or adverse effects between groups. CONCLUSIONS: We found that the addition of clonidine 2 microg.kg-1 to 0.125% bupivacaine with fresh epinephrine 1:200,000 for caudal analgesia did not significantly delay the time to first rescue analgesic or decrease the overall need for rescue analgesics in children 2-8 years undergoing surgical procedures below the umbilicus.

The pharmacokinetics of the intravenous formulation of fentanyl citrate administered orally in children undergoing general anesthesia.

The bioavailability of oral transmucosal fentanyl citrate (OTFC) in children is similar to that of fentanyl solution administered orally to adults. We hypothesized that administering an oral fentanyl solution to children would result in similar fentanyl plasma concentrations and pharmacokinetic variables as administering comparable doses of OTFC. In this pilot study, 10 healthy children requiring postoperative analgesia were enrolled. Each received the undiluted IV fentanyl formulation orally (approximately 10-15 microg/kg; maximum, 400 microg). Venous blood samples were collected from 15 to 600 min after administration. Pharmacokinetic variables were determined using noncompartmental analysis and were compared with a previously studied population of children who received a similar dose of OTFC. Pharmacokinetic variables for the orally administered IV fentanyl formulation were as follows: time to reach peak concentration = 1.7 +/- 1.6 h, peak concentration = 1.83 +/- 1.19 ng/mL, half-life = 4.7 +/- 2.8 h, area under the plasma concentration time curve = 6.46 +/- 3.96 h . ng(-1) . mL(-1), apparent oral volume of distribution (V/F) = 17.5 +/- 7.2 L/kg, apparent oral clearance (CL/F) = 3.33 +/- 2.25 L . kg(-1) . h(-1). Although both OTFC and orally administered IV fentanyl resulted in similar pharmacokinetic variables and plasma concentrations for a given dose, there was marked interpatient variability, particularly in the early hours after oral administration of the IV formulation of fentanyl. This suggests that this method of administration be used with caution until further data are available.

Patient-controlled epidural analgesia in children: can they do it?

UNLABELLED: Extensive clinical experience and many studies support the use of i.v. patient-controlled analgesia (i.v. PCA) and regional anesthesia techniques for the treatment of postoperative pain in children. In contrast, little has been reported about the ability of children to use patient-controlled epidural analgesia (PCEA) or about the efficacy of this technique. We report a descriptive analysis of prospectively recorded data in 128 children (132 procedures) in whom PCEA was used for acute postoperative pain control. Satisfactory analgesia was obtained in 119 patients (90.1%) for up to 103 h with no episodes of desaturation and without clinical evidence of toxicity or serious adverse effects. Analgesia was satisfactory with the initial settings in 89 patients; in 38 others, this was achieved with changes in PCEA settings or solution. Five patients were switched to i.v. PCA because of inadequate analgesia. Eight patients with satisfactory analgesia were converted to i.v. PCA because of adverse effects. Children as young as 5 yr had the cognitive ability to understand and the willingness to use PCEA, consistent with reported use of i.v. PCA. Careful attention should be paid to the total hourly local anesthetic dose to avoid exceeding the recommended limits. Our prospectively collected data demonstrate that PCEA provides satisfactory analgesia with a small incidence of adverse side effects in children and should be considered along with other strategies in pediatric postoperative pain management. IMPLICATIONS: A descriptive analysis of prospectively recorded data in 132 children receiving patient-controlled epidural analgesia for postoperative pain relief demonstrates satisfactory analgesia without serious toxicity or side effects in children as young as 5 yr. This modality should be considered as another strategy in pediatric postoperative pain management.

Uptake pharmacokinetics of the Fentanyl Oralet in children scheduled for central venous access removal: implications for the timing of initiating painful procedures.

BACKGROUND: The Fentanyl Oralet (Abbott Laboratories, Abbott Park, IL, USA) is an oral transmucosal drug delivery system. We previously examined pharmacokinetic parameters of children who had completed consumption of the Fentanyl Oralet. The present study was designed to clarify pharmacokinetic parameters during the consumption phase to determine if there is an optimal administration time before painful procedures. METHODS: Patients, aged 3-10 years, who were scheduled for elective removal of central venous access devices under general anaesthesia, received a Fentanyl Oralet (fentanyl 10-15 microg x kg(-1)). Plasma fentanyl concentrations were measured by radioimmunoassay. Data from blood samples obtained during and after consumption of the Fentanyl Oralet from 17 patients in the present study were combined with data from our previous study to better characterize both the consumption and postconsumption concentration versus time profiles. RESULTS: Estimated fentanyl bioavailability (mean +/- SD) was low (36.1 +/- 0.4%), as were peak plasma concentrations (1.03 +/- 0.31 ng.ml-1), suggesting that many children swallowed a large fraction of the dose. This led to a relatively late and variable peak concentration time of 53 +/- 40 min. In addition, because of the apparently large degree of gastrointestinal absorption, concentration versus time curves were wide and flat. CONCLUSIONS: The wide and flat concentration versus time profile may allow flexibility in the timing of a painful procedure following Fentanyl Oralet administration. However, the variability of the time to peak concentration makes it difficult to suggest a minimum interval between Fentanyl Oralet consumption and the start of a painful procedure.

An evaluation of the efficacy and tolerability of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children.

UNLABELLED: In this double-blinded, randomized, multicenter study, we examined analgesic efficacy and tolerability of tramadol in postoperative pediatric patients. Eighty-one postsurgical ASA physical status I and II patients ages 7-16 yr received oral tramadol (approximately 1 or 2 mg/kg) for postoperative analgesia when they were ready to transition from morphine patient-controlled analgesia to oral analgesics. Rescue analgesia consisted of morphine patient-controlled analgesia or an oral equivalent dose of oxycodone. Patients rated their pain just before the administration of tramadol and at regular intervals for 8 h afterwards using the Wong-Baker Faces Pain Rating Scale. The 2-mg/kg group required approximately half as much rescue analgesia as the 1-mg/kg group (P = 0.006). Parents rated the larger dose more favorably. Adverse events were generally mild to moderate in severity (vomiting [10%], nausea [9%], pruritus [7%], rash [4%]) and similar between the two treatment groups. There were no significant changes in hemodynamic variables, respiratory rate, or SpO(2) percentages between the two treatment groups or in all patients compared with pretreatment values. IMPLICATIONS: Oral tramadol 1-2 mg/kg is well tolerated and effective in postoperative children ready to transition from morphine patient-controlled analgesia. The group receiving 2 mg/kg required less rescue analgesic compared with those receiving 1 mg/kg.

Age-stratified pharmacokinetics of ketorolac tromethamine in pediatric surgical patients.

UNLABELLED: Published data suggest that ketorolac pharmacokinetics are different in children than in adults. We sought to better characterize ketorolac pharmacokinetics in children. Thirty-six children, aged 1-16 yr, were stratified into four age groups: 1-3 yr, 4-7 yr, 8-11 yr, and 12-16 yr. Each child received 0.5 mg/kg of ketorolac tromethamine IV after completion of elective surgery. A maximum of 16 venous blood samples (mean, 13 +/- 2) were collected at predetermined times up to 10 h after drug administration. Plasma ketorolac concentrations were measured by high-performance liquid chromatography after solid-phase extraction. Individual concentration-versus-time relationships were best fit to a two-compartment pharmacokinetic model by using SAAM II. Body weight-normalized pharmacokinetic variables did not differ among the age groups and were similar to those reported for adults, including a volume of distribution at steady state of 113 +/- 33 mL/kg (mean +/- SD) and an elimination clearance of 0.57 +/- 0.17 mL x min(-1) x kg(-1). Our study demonstrates that a single dose of ketorolac (0.5 mg/kg) results in plasma concentrations in the adult therapeutic concentration range for 6 h in most children. Our data provide no evidence that children require either larger weight-adjusted doses or shorter dosing intervals than adults to provide similar plasma drug concentrations. IMPLICATIONS: The literature suggests that ketorolac disposition differs between children and adults. We characterized ketorolac pharmacokinetics in 36 children. Body weight-normalized two-compartment pharmacokinetic variables did not differ among pediatric patients <17 yr old and were similar to adult values.