Constance S. Houck

A double-blind evaluation of ketorolac tromethamine versus acetaminophen in pediatric tonsillectomy: analgesia and bleeding.

The study was designed to compare intravenous ketorolac to rectal acetaminophen for analgesia and bleeding in pediatric patients undergoing tonsillectomy.We studied 50 patients, aged 2-15 yr undergoing tonsillectomy with or without adenoidectomy. In a randomized, prospective double-blind fashion, patients were assigned to receive either ketorolac (1 mg/kg) or rectal acetaminophen (35 mg/kg). Bleeding was evaluated by measuring intraoperative blood loss and noting extra measures required to obtain hemostasis. Bleeding times were also measured before and during surgery. Pain was evaluated using a standard objective pain score for the first 3 h. Persistent pain was treated with morphine, acetaminophen, and codeine and recorded for 24 h. Blood for determination of acetaminophen levels was drawn at 20 and 40 min after the administration of study drugs. Pain scores were not significantly different between the ketorolac and acetaminophen groups. The majority of patients in both groups required additional opioid in the postoperative period. Acetaminophen levels were all less than the therapeutic range. Intraoperative bleeding times were normal in all patients, but blood loss was significantly higher in the ketorolac group (2.67 mL/kg) compared to the acetaminophen group (1.44 mL/kg), P = 0.025. Significantly more measures to achieve hemostasis were required in the ketorolac group (P = 0.012). We conclude that ketorolac is no more effective than high-dose rectal acetaminophen for analgesia in the patient undergoing tonsillectomy. Hemostasis during tonsillectomy was significantly more difficult to achieve in patients receiving ketorolac. (Anesth Analg 1995;80:226-9)

The value of end-tidal CO2 monitoring when comparing three methods of conscious sedation for children undergoing painful procedures in the emergency department.

Background: Many studies have evaluated conscious sedation regimens commonly used in pediatric patients. Recent advances in capnography equipment now enable physicians to assess respiratory parameters, specifically end-tidal CO2 (et-CO2), more accurately in spontaneously breathing sedated children than was possible in the earlier studies. This study was designed to: 1) compare the safety and efficacy of intravenous fentanyl, intravenous fentanyl combined with midazolam, and intramuscular meperidine-promethazine-chlorpromazine (MPC) compound when used for painful emergency department (ED) procedures; and 2) to determine whether the addition of et- CO2 monitoring enabled earlier identification of respiratory depression in this population. Methods: Forty-two children requiring analgesia and sedation for painful ED procedures were randomly assigned to receive either fentanyl, fentanyl-midazolam, or MPC compound. Vital signs, oxygen saturation, and et-CO2 were monitored continuously. Pain, anxiety, and sedation scores were recorded every five minutes. Results: Respiratory depression (O2 saturation ≤ 90% for over one minute or any et-CO2 ≥ 50) occurred in 20% of fentanyl, 23% of fentanyl-midazolam, and 11% of MPC patients (P=NS). Of those patients manifesting respiratory depression, 6/8 were detected by increased et-CO2 only. MPC patients required significantly longer periods of time to meet discharge criteria than fentanyl and fentanyl-midazolam patients (P<0.05). No differences were noted in peak pain, anxiety, or sedation scores. Conclusions: Fentanyl, fentanyl-midazolam, and MPC produced a high incidence of subclinical respiratory depression. End-tidal CO2 monitoring provided an earlier indication of respiratory depression than pulse oximetry and respiratory rate alone. MPC administration resulted in a significantly delayed discharge from the ED.

Patient-controlled analgesia for mucositis pain in children: A three-period crossover study comparing morphine and hydromorphone

OBJECTIVES (1) To test the safety and efficacy of a clinical protocol for administering opioid by using patient-controlled analgesia (PCA) for the management of mucositis pain in children after bone marrow transplantation, (2) to compare the efficacy, side-effect profile, and potency ratio of morphine with those of hydromorphone by using PCA as the method of opioid administration, and (3) to obtain pharmacokinetic data on hydromorphone and morphine in this population of children. METHODS In this double-blind, three-period crossover study, patients were randomly assigned to receive either morphine (group 1) or hydromorphone (group 2) initially by means of PCA on days 1, 2, and 3 (period 1), to be followed on days 4, 5, and 6 (period 2) with the alternative opioid, followed by the opioid used at the commencement of the study on days 7, 8, and 9 (period 3). A clinical protocol for calculating the PCA commencement opioid dose and subsequent opioid-dose escalation was tested by measures of safety and efficacy. Measures of pain intensity and opioid side effects were made during the three periods. On the last study day (day 10), patients received a continuous infusion of opioid derived from the previous 24-hour PCA opioid requirement, and blood specimens were collected and stored for subsequent opioid analysis. RESULTS Ten patients were enrolled in this study. Rapid escalation in opioid requirement commonly occurred at the commencement of PCA, followed by a variable plateau phase and then deescalation of opioid requirement after mucositis resolution. The measures demonstrated the safety and efficacy of the clinical protocol. In the concentrations used, there was no statistical difference between the mean daily pain, sedation, nausea and vomiting, and pruritus scores for both opioids (Friedman test). The analysis of variance of the log-total opioid doses per patient during periods 1, 2, and 3 indicated that patients used 27% more hydromorphone than expected from its presumed 7:1 ratio relative to morphine potency used in the PCA infusions. The mean plasma hydromorphone concentration was 4.7 ng/ml (range, 1.9 to 8.9 ng/ml), and the mean clearance was 51.7 ml/min per kilogram of body weight (range, 28.6 to 98.2 ml/min per kilogram). The mean plasma morphine, morphine-6-glucuronide, and morphine-3-glucuronide concentrations were 40.0 ng/ml (range, 15 to 62.5), 168.2 ng/ml (range, 54.4 to 231.9), and 391.0 ng/ml (range, 149.4 to 921.7), respectively. The mean morphine clearance was 34.3 ml/min per kilogram of body weight (range, 19.3 to 58.3). The mean molar ratios of morphine-6-glucuronide/morphine, morphine-3-glucoronide/morphine, and morphine-3-glucuronide/morphine-6-glucuronide were 2.48 (range, 1.4 to 3.3), 5.82 (range, 3.4 to 9.1), and 2.46 (range, 1.1 to 3.3), respectively. CONCLUSIONS The safety and efficacy of a clinical protocol for the administration of opioids by means of PCA for mucositis pain after bone marrow transplantation was demonstrated. In this small study, hydromorphone was not superior to morphine in terms of analgesia or the side-effect profile: a larger study would be needed to show a difference. The clearances of hydromorphone and morphine in the children studied were generally greater than those previously recorded, but this finding may be related to disease or treatment variables. Apart from clearance, the morphine pharmacokinetics in the study population were similar to those previously recorded. Hydromorphone may be less potent in this population of children than indicated by adult equipotency tables.

Robotic Assisted Laparoscopic Ureteral Reimplantation in Children: Case Matched Comparative Study With Open Surgical Approach

PURPOSE Surgical treatment may be required in some patients with vesicoureteral reflux. With the recent development of robotic assistance, laparoscopic treatment of vesicoureteral reflux has gained popularity. We sought to evaluate our initial experience with pediatric robotic assisted laparoscopic intravesical and extravesical ureteral reimplantation, and to compare outcomes with the open technique. MATERIALS AND METHODS A retrospective chart review was performed on all patients who underwent robotic assisted laparoscopic ureteral reimplantation between 2007 and 2010. Comparisons were made with a case matched cohort of patients who underwent the open technique. The groups were compared using t tests for numerical variables and chi-square comparisons or Fishers exact test for categorical variables. A Kaplan-Meier model was used to compare success rates. RESULTS A total of 19 patients underwent intravesical and 20 underwent extravesical robotic assisted laparoscopic ureteral reimplantation during the study period. They were compared to 22 patients undergoing intravesical and 17 undergoing extravesical open ureteral reimplantation. Although the robotic assisted approach was associated with a longer operative time (p <0.001), children undergoing intravesical robotic assisted reimplantation had a shorter duration of urinary catheter drainage, fewer bladder spasms and a shorter hospital stay compared to those undergoing the intravesical open technique (p <0.01). There were no significant differences in these parameters when comparing extravesical robotic assisted reimplantation to the extravesical open technique. Overall success rates were similar among patients who underwent robotic assisted laparoscopic ureteral reimplantation and open reimplantation (p >0.5). CONCLUSIONS Robotic assisted laparoscopic ureteral reimplantation offers similar success rates to the gold standard, open ureteral reimplantation. Future large scale studies will be required to define further the costs and benefits of robotic assisted laparoscopic ureteral reimplantation in the surgical treatment of vesicoureteral reflux.

Long-term experience and outcomes of robotic assisted laparoscopic pyeloplasty in children and young adults.

PURPOSE Laparoscopic pyeloplasty is one of the more common robotic assisted procedures performed in children. However, data regarding long-term experience and clinical outcomes for this procedure are limited. We evaluated the long-term outcomes in a large series of patients undergoing robotic assisted laparoscopic pyeloplasty at a teaching institution, and the effect of a collaborative program between the robotic surgeons, surgical nurses and anesthesiologists on overall operative time. MATERIALS AND METHODS We retrospectively reviewed 155 patients who underwent robotic assisted laparoscopic pyeloplasty between 2002 and 2009. Operative data, including surgical approach, type of procedure, total and specific operative times and placement of ureteral stents, were determined. Postoperative outcome measurements, including duration of hospital stay, duration of Foley catheter drainage, radiological findings and any subsequent complications, were assessed. RESULTS Mean operative time and length of hospitalization decreased significantly by the end of the study. At a mean followup of 31.7 months the primary success rate was 96% (hydronephrosis was improved in 85% of patients and stable in 11%). The complication rate was 11%, and recurrent obstruction requiring redo robotic assisted laparoscopic pyeloplasty or open pyeloplasty developed in 3% of patients. Success rate and complication rate were unchanged during the study period. CONCLUSIONS This study confirms that even within the confines of a pediatric urology training program successful collaboration between robotic surgeons, surgical nurses and anesthesiologists can lead to shorter operative times and hospital stays. Long-term surgical success and complication rates were comparable to open surgery.

Thoracic epidural catheters placed by the caudal route in infants: the importance of radiographic confirmation.

Background: Cephalad advancement of epidural catheters to the thoracic region via the caudal route has been shown to be feasible in neonates and small infants. This has allowed many young infants to receive thoracic level epidural analgesia with dilute local anaesthetic solutions using the simpler caudal approach. Since radiographic confirmation of the catheter tip is routine at this institution, we wished to determine how often radiographic studies led to adjustment or replacement of the epidural catheter.

Ketorolac suppresses postoperative bladder spasms after pediatric ureteral reimplantation.

We evaluated the efficacy of ketorolac in suppressing postoperative bladder spasms after ureteroneocystostomy (ureteral reimplantation). Twenty-four pediatric patients undergoing intravesical ureteroneocystostomy were enrolled prospectively to receive either ketorolac or placebo via double-blinded randomization. Twelve patients in each group shared similar preoperative characteristics. All were maintained on an epidural infusion of bupivacaine (0.1%) with fentanyl (2 &mgr;g/mL) throughout the study. Patients were given either ketorolac (0.5 mg · kg-1 · dose-1) or placebo (equivalent volume saline) IV after surgery and every 6 h thereafter for 48 h. Parents were instructed to record bladder spasm episodes prospectively by using a standardized time-flow diary. Three patients (25%) in the ketorolac group experienced bladder spasms, compared with 10 patients (83%) in the placebo group (two-sided P < 0.05). The median severity score for the ketorolac group was 1.2 (mild = 1.0, severe = 3.0), compared with 2.6 for the placebo group (P = 0.003). We conclude that IV ketorolac reduces the frequency and severity of postoperative bladder spasms after intravesical ureteroneocystostomy. Implications We studied the efficacy of ketorolac, a prostaglandin synthesis inhibitor, in the treatment of bladder spasm after ureteroneocystostomy (antireflux operation). Patients were randomized in a double-blinded manner to receive either ketorolac or placebo after the surgery. We demonstrate that ketorolac reduces the frequency and severity of postoperative bladder spasm.

Safety of intravenous ketorolac therapy in children and cost savings with a unit dosing system

OBJECTIVE To determine the incidence of side effects with the short-term use of intravenously administered ketorolac in children and the overall cost savings with a unit dosing system. STUDY DESIGN We prospectively examined the incidence of complications arising from the intravenous administration of ketorolac to 1747 children (14,810 doses) during a 3-year, 3-month period and assessed cost savings resulting from dividing 60 mg syringes into 7.5, 15, 30, and 60 mg unit doses. Complications were recorded prospectively into a computerized database. Estimated drug costs to the pharmacy were calculated on the basis of the total numbers of each drug fraction administered, with allowance for 1O% wastage as a result of drug expiration. RESULTS Side effects occurring with ketorolac administration were rare. Four patients (0.2%) had hypersensitivity reactions to the drug, two of them possibly on the basis of latex allergy. Two patients (O.1%) had renal complications but were subsequently found to have underlying causes that could account for their renal symptoms. One patient (0.05%) had massive gastrointestinal bleeding in the postoperative period. With fractionation of 60 mg syringes, total drug cost to the pharmacy was

A Comparative Direct Cost Analysis of Pediatric Urologic Robot-Assisted Laparoscopic Surgery Versus Open Surgery: Could Robot-Assisted Surgery Be Less Expensive?

34,786, rather than the

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86,639 that would have been spent had a single syringe been used for each dose. CONCLUSION Ketorolac proved safe for short-term intravenous use in children more than 1 year of age when patients with known contraindications to the use of non-steroidal antiinflammatory drugs were excluded. A considerable reduction in drug costs can be achieved with fractionation of premixed syringes into unit doses.