Antidepressants for functional gastrointestinal disorders in children

Question Functional gastrointestinal disorders (FGIDs) are complex conditions I see in some of my pediatric patients. The indications for antidepressants such as selective serotonin reuptake inhibitors (SSRIs) do not include treatment of FGIDs; however, some children are prescribed SSRIs for this condition. Are antidepressants effective and safe to use for treating FGIDs in children and adolescents?Answer The pathogenesis of FGIDs is largely idiopathic, and although theories exist to explain why SSRIs might be used to treat FGIDs, there is no conclusive evidence of their effectiveness. No large, well controlled studies have investigated the use of SSRIs to treat FGIDs in the pediatric population. There is also evidence that suggests an increased risk of suicidal thoughts when adolescents use SSRIs. Currently, there is no recommendation to use SSRIs to treat FGIDs in children.     

Amantadine in pediatric patients with traumatic brain injury: a retrospective, case-controlled study

OBJECTIVE: To determine if amantadine use in pediatric patients with traumatic brain injury is well tolerated and to attempt to assess its effectiveness. DESIGN: This was a retrospective, case-controlled study. RESULTS: Of the 54 patients, aged 3-18 yrs, who were administered amantadine, five (9%) had side effects that might have been related to the drug. These included hallucinations, delusions, increased aggression, and nausea/vomiting. The side effects were reversed when the medication was stopped or the dosage decreased. Patients in the amantadine group had a greater increase in Ranchos Los Amigos level during their admission than those in the control group (median, 3 vs. 2; P < 0.01). This difference may be, at least in part, explained by the fact that the amantadine group started at a lower Ranchos Los Amigos level (median, 3 vs. 4; P < 0.01). There were subjective improvements noted in 29 of the 46 patients (63%) in the amantadine group whose full charts were available for review. CONCLUSION: Amantadine is a well tolerated medication when it is used in pediatric patients with traumatic brain injury. Subjective improvements were noted in the majority of the patients administered amantadine, and the amantadine group showed a greater improvement in Ranchos Los Amigos level during admission, suggesting that it may be effective.     

Is ondansetron safe for use during pregnancy?

Question While I usually prescribe doxylamine-pyridoxine for morning sickness, some of my patients with severe nausea and vomiting of pregnancy (NVP) receive ondansetron in hospital. I have read some new precautions recommended by the US Food and Drug Administration (FDA). Is ondansetron safe to use during pregnancy?Answer During the past decade ondansetron has been increasingly used in the United States for NVP, owing to the lack of an FDA-approved drug for this condition. While fetal safety data for doxylamine-pyridoxine are based on more than a quarter of a million pregnancies, the fetal safety data for ondansetron are based on fewer than 200 births. Moreover, a recent case-control study suggested there was an increased risk of cleft palate associated with ondansetron. Recently, the FDA issued a warning about potentially serious QT prolongation and torsade de pointes associated with ondansetron use; the warning included a list of precautions and tests that must be followed. The drug is not labeled for use in NVP in either the United States or Canada. Based on the data available today, ondansetron use cannot be assumed to be safe during pregnancy.     

Pediatric laparoscopy

SIGNIFICANT DEVELOPMENTS in minimally invasive surgery (MIS) for the adult population have led to increased application of MIS techniques for pediatric patients.LAPAROSCOPY IS THE MOST COMMON MIS procedure used in pediatrics. Traditional surgical procedures that are now being performed laparoscopically include gastrostomy, pyloromyotomy, and repair of congenital diaphragmatic hernia and imperforate anus.ALL PERIOPERATIVE TEAM MEMBERS must be prepared to provide appropriately sized instruments and equipment to facilitate use of MIS techniques in the pediatric population and must ensure safe patient care to achieve optimal patient outcomes. AORN J 88 (August 2008) 211-236. © AORN, Inc, 2008.     

Addition of levalbuterol to a pediatric emergency department automated medication management system does not increase its use

Background

Although adding a drug to an emergency department-based automated medication management system is known to increase how frequently it is ordered, little is known about this effect when the added drug does not offer substantial benefit over a substitute drug that was already available.

Aims

We studied the effect of adding nebulized levalbuterol to a pediatric emergency department-based automated medication management system that already included albuterol.

Methods

All completed orders for nebulized levalbuterol or nebulized albuterol from our academic pediatric emergency department were retrospectively identified using a computerized pharmacy database. We compared ordering of these drugs for the year before levalbuterol was added to the automated medication management system, during which it was available only from the hospital central pharmacy via a pneumatic tube system, with the year following its inclusion in the system.

Results

There were 6 orders for nebulized levalbuterol and 1,295 orders for nebulized albuterol during the year that levalbuterol was only available from the hospital central pharmacy, and 7 orders for nebulized levalbuterol and 1,108 orders for nebulized albuterol during the year following levalbuterol’s inclusion in the automated medication management system. There was no significant difference (p?=?0.78).

Conclusions

Use of nebulized levalbuterol, in relation to that of nebulized albuterol, for which it is a substitute, did not significantly change when it was included in the pediatric emergency department automated medication management system. This may reflect the lack of substantial benefit that levalbuterol offers over nebulized albuterol in managing children in the emergency department.     

Medication administration errors and the pediatric population: a systematic search of the literature

Medication administration errors are a serious concern for the pediatric population. This article presented an overview of medication errors and safe medication administration practices. Additional information was presented regarding the pediatric population and specific factors that make this population susceptible to medication errors. A systematic literature search on medication administration errors in the pediatric population was presented. From the search, five themes emerged, including the incidence rate of medication administration errors, specific medications involved in medication administration errors and classification of the errors, why medication administration errors occur, medication error reporting, and interventions to reduce medication errors.Differences in study design made it difficult to compare the articles with regard to some of the themes. However, it was apparent that medication administration errors do occur in the pediatric population, regardless of the exact incidence rate. As previously stated, the NCC MERP believes that there is no acceptable incidence rate for medication errors. Errors in dosage were found to be a common reason as to why medication errors occur. There was some discrepancy with regard to medication error reporting, as it was found that medication errors are underreported, but the extent of this varied. Systems used to report medication errors also varied. It was found that the more detailed the information reported on the medication error, the more potential impact it had on leading to a system change to prevent such errors from occurring again. It is recommended that reporting systems be nonpunitive so that nurses are not afraid to report errors. In addition, more emphasis should be placed on near miss medication errors, as these occur frequently but are rarely reported and may provide greater insight into system flaws. Lastly, interventions found to reduce medication administration errors were congruent with current recommendations for safe medication administration. This calls into question if the current recommendations are being followed uniformly. Implications for future research and practice include that a formalized system check for safe medication administration be developed and utilized. System checks have been developed and are widely used during the prescribing and preparing stage, and less medication errors are noted during this early part of the medication process. Having a formalized system check during medication administration would aid in ensuring that current recommendations are being followed, which would lead to a decrease in medication administration errors.Parents and caregivers naturally expect that their children will be safe when in the health care system. Yet, providing health care will always involve some degree of risk due to both the complexity of the health care environment and the role that human judgment plays within it. Nurses play a role in improving the safety of children within their care. The role of the nurse is much wider than simply reporting patient safety incidents or near misses; it includes taking preventative actions, sharing experiences, learning from mistakes, and helping to devise solutions.     

Regional variations in pediatric medication exposure: Spatial analysis of poison center utilization in western Pennsylvania

Context Medication drug exposures among young children continue to rise despite current poison prevention efforts. These exposures result in increased healthcare utilization and medical costs. New tactics are needed to reduce injuries related to pediatric drug exposures. Objective We aimed to identify cluster patterns in: (1) calls for pediatric medication drug exposures and (2) a subset of calls that resulted in medical evaluation referrals. We identified and evaluated population characteristics associated with cluster patterns. Methods We analyzed 26?685 pharmaceutical drug exposures involving children <5 years of age based on calls reported to the Pittsburgh Poison Center from 1 January 2006 to 31 December 2010. We performed spatial statistics to assess for clustering. We used logistic regression to estimate population characteristics associated with clustering. Results Spatial analysis identified 22 exposure clusters and five referral clusters. Sixty-five percent of 89 ZIP codes in the clusters of drug exposure with healthcare facility (HCF) referral were not identified in the exposure clusters. ZIP codes in the HCF referral clusters were characterized as rural, impoverished, and with high rates of unemployment and school dropouts. Discussion Our principal findings demonstrate pediatric drug exposures do exist in discrete geographic clusters and with distinct socioeconomic characteristics. Conclusion This study offers a starting point for subsequent investigations into the geographic and social context of pediatric medication drug exposures. This is an important step in revising pediatric poison prevention strategies.     

Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy/Adenoidectomy: A Pilot Study

PurposeTo examine the effects of preoperative gabapentin administration on postoperative pain in pediatric patients undergoing tonsillectomy/adenoidectomy (T/A) in a single ambulatory surgery location within a pediatric healthcare organization.DesignThis randomized, controlled pilot study enrolled patients age 3–18 years with American Society of Anesthesiologists (ASA) scores of I-II undergoing T/A.MethodsBoth gabapentin and placebo groups were given study medication preoperatively and received standard opiate regimens intraoperatively and postoperative pain instructions. Outcome measurements included: time to first analgesic medication in the postanesthesia care unit (PACU), mean acetaminophen, ibuprofen, and opiate doses in mg/kg. Additionally, we examined pain scores, medication use, and side effects reported by daily pain diaries completed by patients/families for 3 days postoperatively.FindingsForty-nine patients were included in final analysis (gabapentin n = 26, placebo n = 23). Demographic and clinical characteristics of both groups were similar; the majority (46 of 49) were under the age of 13.Both groups received opiates in PACU. Some patients in both groups received hydrocodone/acetaminophen postoperatively. There were no reported differences in side effects between groups. Gabapentin group reported less use of opiates, acetaminophen, and ibuprofen post-discharge. We identified small effect sizes for opiates and acetaminophen, and medium effect size for ibuprofen (80.1% gabapentin versus 100% placebo, RR 0.81 [95% CI 0.67–0.97]).Median pain scores were 4 on a scale of 10 for both groups for all 3 days of follow-up. Overall median satisfaction score was 9, with a mean difference of 0.35 (95% CI -0.78 – 1.37). Analysis of variance revealed no difference in pain scores or satisfaction per pain diaries between the groups in general and no difference in score trajectory.ConclusionsWe were able to establish a rigorous process and feasibility to launch a larger, multi-center trial to examine this important issue. There remain few evidence-based options for acute pain relief in pediatric surgical populations besides opiates^. Identifying opiate alternatives that are effective, cost efficient and safe are needed for pediatric tonsillectomy patients.     

A year in review: new drugs for older adults in 2011

BackgroundNew drugs approved by the Food and Drug Administration (FDA) may offer tremendous clinical advances by providing health care providers with new treatment strategies. However, additional care must be taken for safe and effective use of these new agents by older adults.ObjectiveOur objective was to identify FDA-approved medications in 2011 most likely to be prescribed to older adults, and to describe medication characteristics that may require special attention in this population.MethodsThe FDA Web site was reviewed for new drug approvals from January through December 2011. Approved labeling for each drug was obtained from the manufacturer's Web site and PubMed was searched for primary literature published between 1967 and 2012.ResultsRivaroxaban, an oral factor Xa inhibitor, is approved for once-daily use in treatment of nonvalvular atrial fibrillation and deep vein thrombosis prophylaxis after replacement of a hip or knee. Drug interactions and renal function must be considered when prescribing this drug to older adults. Fidaxomicin is an oral anti-infective approved for the treatment of Clostridium difficile-associated diarrhea. It has minimal oral absorption or side effects, no relevant drug interactions, but a very high cost. It is a treatment option after failure of oral metronidazole and oral vancomycin. Roflumilast is a selective inhibitor of phosphodiesterase 4 and is approved to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD and a history of exacerbations. It is recommended as a second or alternative choice combined with a long-acting bronchodilator in patients at high risk for hospitalization. Indacaterol is an inhaled long-acting β-agonist approved for COPD maintenance. It is administered once daily, which may improve adherence in older adults compared with currently available twice-daily agents.ConclusionsFour new drugs approved in 2011 applicable to the geriatric population are presented. Clinicians must consider the available evidence, cost, drug–drug interactions, renal function, pharmacokinetic/pharmacodynamic differences, and patient preferences when considering prescribing these agents to older adults.     

Influence of CYP2D6 metabolizer status on ondansetron efficacy in pediatric patients undergoing hematopoietic stem cell transplantation: A case series

Chemotherapy‐induced nausea and vomiting (CINV) is commonly experienced by patients receiving antineoplastic agents prior to hemopoietic stem cell transplant (HSCT). Ondansetron, a 5‐HT3 antagonist metabolized by CYP2D6, is an antiemetic prescribed to treat short‐term CINV, but some patients still experience uncontrolled nausea and vomiting while taking ondansetron. Adult CYP2D6 ultrarapid metabolizers (UMs) are at higher risk for CINV due to rapid ondansetron clearance, but similar studies have not been performed in pediatric patients. We performed a retrospective chart review of 128 pediatric HSCT recipients who received ondansetron for CINV prevention and had CYP2D6 genotyping for 20 alleles and duplication detection. The number of emetic episodes for each patient was collected from the start of chemotherapy through 7 days after HSCT. The average age of the cohort was 6.6 years (range: 0.2–16.7) and included three UMs, 72 normal metabolizers, 47 intermediate metabolizers, and six poor metabolizers. Because UMs are the population at risk for inefficacy, we describe the course of treatment for these three patients, as well as the factors influencing emesis: chemotherapy emetogenicity, diagnosis, and duration of ondansetron administration. The cases described support guidelines recommending non‐CYP2D6 metabolized antiemetics (e.g., granisetron) when a patient is a known CYP2D6 UM, but pediatric studies with a larger sample of CYP2D6 UMs are needed to validate our findings.

Study Highlights

• WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC?

In adults, ondansetron is not as effective for chemotherapy‐induced nausea and vomiting (CINV) in CYP2D6 ultrarapid metabolizers (UMs) compared to non‐UMs. Ondansetron is a medication commonly prescribed to pediatric patients, especially for CINV.

• WHAT QUESTION DID THIS STUDY ADDRESS?

Our study describes the efficacy of ondansetron for CINV in three pediatric CYP2D6 UMs.

• WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE?

Pediatric CYP2D6 UMs experienced more emesis when taking ondansetron for CINV on days where they did not receive opioids than expected, similar to findings in adults.

• HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE?

Based on these findings, at our institution, any patient undergoing a bone marrow transplant that is a CYP2D6 UM will receive granisetron rather than ondansetron; this practice may be applicable to pediatric patients at other institutions.     

Initiation and management of a pediatric multicenter drug trial by an academic center

Background: Although the number of prospective pediatric drug trials has increased in the past few years, there are still fewer studies done in pediatric patients than in adults. Such studies are critical for determining the safety, efficacy, and appropriate dosing of drugs in children.Objectives: This article outlines the difficulties encountered in initiating and performing multicenter drug studies in children and offers recommendations for developing and conducting such studies.Methods: We reviewed existing literature in pediatric drug trials, searching PubMed and reviewing topics in such trials, and analyzing our own experience.Results: Recent legislation offers financial incentives to pharmaceutical companies to conduct clinical trials in pediatric patients; however, obstacles to the successful initiation and completion of such trials still exist. Pediatric centers are often inexperienced at developing clinical trial protocols and applying for research grants. In addition, many drugs cannot be administered at appropriate doses to smaller patients in tablet or capsule form, making it necessary to develop new formulations. Furthermore, parents may be reluctant to allow their children to participate in placebo-controlled trials. Pediatricians interested in developing drug trials must plan carefully to anticipate all of the budgetary, staffing, regulatory, and enrollment problems that may arise over the course of such a trial.Conclusions: More trials are needed to determine the safety, efficacy, and optimal doses of new drugs and of drugs already used off-label to treat pediatric patients. The financial incentives offered by legislation provide additional reasons for pediatricians and industry to work together to perform drug trials in pediatric patients.     

A retrospective review of whole bowel irrigation in pediatric patients

Abstract

Background. Traditionally whole bowel irrigation (WBI) has been advocated for ingestions involving substances not bound with activated charcoal as well as extended release and enteric coated medications. Other than isolated case reports, little exists in the literature regarding the use of WBI in poisoned pediatric patients. The purpose of this study is to better understand the use of WBI in pediatric patients. Method. A retrospective chart review of California Poison Control System electronic database for human poisoning cases between the years 2000 and 2010 was performed. Results. A total of 176 cases were identified. The most common age of poisoned patients that received WBI was 2 years. There were more pediatric patients who received WBI between 2000 and 2005 then between 2006 and 2010. The top three substances in which WBI was used were calcium channel blockers, iron, and antidepressants. There were 72 cases involving sustained release and delayed release substances. The top five sustained release/delayed release substances were nifedipine, bupropion, verapamil, diltiazem, and felodipine. Adverse drug reactions were noted in 17 patients, vomiting in 16 patients and abdominal pain in one patient. In 36 cases, abdominal radiographs were performed. Sixteen were positive, and in four cases, repeat abdominal radiographs demonstrated a decrease in opacities. Twelve patients had documented pills in their effluent. Conclusion. Transient adverse drug reactions, vomiting and abdominal pain, were associated with WBI. Polyethylene glycol plus electrolyte lavage solution (PEG–ELS) was more frequently administered through the nasogastric tube. Patients who underwent WBI through nasogastric tube received higher doses of PEG–ELS.     

Safety of tacrolimus in pregnancy

Question I have a 30-year-old patient who had a kidney transplant 2 years ago. She is now planning a pregnancy. She has been treated with tacrolimus since her transplant. Will it be safe for the fetus if she continues to take it during the pregnancy or should she switch to a different antirejection medication?Answer If your patient is stable while taking tacrolimus, there is no reason to switch. The current available information does not suggest that tacrolimus increases the risk of major congenital malformations above the baseline risk in the general population. Premature birth and low birth weight are often reported in this population; however, these effects are frequently reported in pregnant transplant patients treated with other immunosuppressant agents and probably reflect the effects of the maternal condition. As there are some reports of hyperkalemia and renal impairment in infants exposed to tacrolimus in utero, kidney function and electrolytes should be monitored in exposed neonates.     

Review on microbiota and effectiveness of probiotics use in older

The aim of the present systematic review is to summarize the existing knowledge about the human microbiota in the elderly and the effects of probiotics in elderly population. The elderly subjects, compared to adult population, show a reduction in the diversity of the microbiota, characterized by a large interindividual variability, with lower numbers of Firmicutes, Bifidobacteria, Clostridium cluster XIV, Faecalibacterium Prausnitzii, Blautia coccoides-Eubacterium rectal and higher presence of Enterobacteriaceae and Bacteroidetes. These differences of the intestinal microbiota of the elderly may not necessarily be caused by aging, but they could be associated with the decline of the general state of health with malnutrition and with increased need for medication, such as antibiotics and nonsteroidal anti-inflammatory drugs, situations that occur frequently in the elderly. Differences have been demonstrated in the composition of the microbiota between healthy elderly subjects and hospitalized or institutionalized elderly subjects. These findings which further indicates that the living conditions, health status, nutrition and drugs have a significant effect on the composition of the microbiota. According to the available knowledge, the use of probiotics is safe and could represent an useful intervention to prevent or treat antibiotic-associated diarrhea, in addition to reducing the severity of symptoms, other than to help the management of constipation.