The current study confirms the high prevalence of unlicensed and off-label drug use in a PICU and NICU setting. Compared with a similar study conducted in the same PICU in 2002, despite regulatory efforts conducted in this area, the prevalence of unlicensed medications was surprisingly higher.
Objectives To compare the efficacy of oral midazolam alone with a combination of oral midazolam and ketamine in children requiring laceration repair.
Objective: To assess the efficacy of oral ketamine versus oral midazolam for sedation during laceration repair at a pediatric emergency department.Methods: Children between 1 and 10 years requiring laceration repair were randomly assigned to 2 groups, treated either with oral midazolam (0.7 mg/kg) or with oral ketamine (5 mg/kg).Main outcomes measured were level of pain during local anesthesia, as assessed by the parent on a 10-cm visual analog scale (VAS) and the number of children who required intravenous sedation. Secondary outcomes included VAS by physician, pain assessment by child, maximal sedation depth assessed by the University of Michigan Sedation Scale, time until University of Michigan Sedation Scale 2 or more, general satisfaction of a parent and treating physician, length of procedure, total sedation time, and the incidence of any adverse events.Results: Sixty-eight children were recruited of which 33 were girls. Average age was 5.08 ± 2.14 years. Thirty-seven children were treated with ketamine and 31 with midazolam. Parent-assessed VAS in ketamine treated patients was 5.07 ± 0.75 compared with 3.68 ± 0.7 in midazolam treated patients [mean difference = 1.39 95% confidence interval (CI) –0.47 to 3.26]. Twelve (32%) of the children treated with ketamine required the addition of IV sedation compared to only 2 children (6%) of the children treated with midazolam [odds ratio (adjusted for age and gender) 6.1, 95% CI: 1.2 to 30.5]. The rest of the measured variables were similar between the groups, with no statistical significance.Discussion: No difference in the level of pain was found between ketamine and midazolam treated patients. Compared with oral midazolam (0.7 mg/kg), oral ketamine (5 mg/kg) was associated with higher rates of sedation failure, and thus is not recommended as a single agent for oral sedation in children requiring laceration repair.
Methylenedioxymethamphetamine (MDMA), commonly known as Ecstasy, is a hallucinogenic compound structurally related to amphetamine. Ecstasy's severe neurological toxicity includes seizures, subarachnoidal hemorrhage, cerebral infarction, intracranial bleeding and cerebral venous thrombosis. We describe the first case of spinal cord damage presenting as acute quadriplegia and respiratory insufficiency in a healthy adolescent following Ecstasy recreational usage.
Background: One aspect of ordering and prescribing medication is the requirement for a trained professional to review medication orders or prescriptions for appropriateness. In practice, this review process is usually performed by a clinical pharmacist. However, in many medical centers there is a shortage of staff and a pharmacist is not always available.Objective: To determine whether remote review of medication orders by a pharmacist is a plausible method in a pediatric intensive care unit (PICU).Methods: A pharmacist from the pharmacy department reviewed medication orders of patients admitted to our PICU over a 7-month period for appropriateness. A special form for medical orders was filled in and sent to the physician in the PICU, who replied informing whether the recommendation had been accepted. The time spent by the pharmacist for this activity was recorded.Results: The review time for one medical record was 8.9 (95% CI, 6.9–10.9) min. Every additional drug prescribed increased the total review time by 0.8 (95% CI, 0.45–1.11) min. The pharmacist filled in 186 forms on 117 admissions for 109 children. The median review time was 15 (12.8–18.8) and 12 (9–15) min, respectively, for patients with psychiatric-neurologic disorders compared to those without (p = 0.032). Usually, a daily workload of 240 min was needed for the pharmacist accompanying the round in contrast to 108 min per day needed to review all the medical records in 95% of the cases. The physician accepted 51.2%, rejected 11.9%, and made no comment on 36.9% of the recommendations.Conclusion: Hospitals facing budget shortages can carry out focused remote reviews of prescriptions by the pharmacist.
Neuroleptic malignant syndrome (NMS) is an uncommon potentially fatal side effect of neuroleptic drugs, characterized by movement disorder, altered mental status and autonomic instability. A single dose of clotiapine was administered to an 11-year old male with acute psychosis. The previously healthy child had signs consistent with NMS including hyperthermia, hypertension, motor and mental changes. Repeat examination performed two weeks later, demonstrated that while his hyperthermia subsided, his mental status deteriorated. Olanzapine was administered, after which the child had hyperthermia, dystonia and more pronounced restlessness, once again consistent with NMS. He developed respiratory failure and was intubated and mechanically ventilated. Lorazepam, dantrolene and bromocriptine were administered as treatment of possible NMS. His mental condition, movement disorder and autonomic dysfunction improved significantly. Two weeks later, the patient was discharged in good general condition without the need for any ongoing medical treatment. There are only few case reports of NMS in children treated with olanzapine, an atypical antipsychotic. In children, caution must be exercised when prescribing antipsychotics, particularly atypical antipsychotics as these drugs may cause NMS. Because of the low incidence of NMS, a high index of suspicion is needed to identify cases so prompt treatment can be undertaken.
Background With the expanding use of Biological Agents (BA), in particular TNF inhibitors, opportunistic infections (OI) are a major concern in Rheumatology. Objectives a) To describe the incidence of OI global and by periods in Rheumatoid Arthritis (RA). b) To compare the risk of OI by BA. Methods We performed a retrospective longitudinal observational study from 1/1/2000 to 23/11/2013. We included subjects followed up in our outpatient clinic, diagnosed with RA according to ACR criteria 87, whom started treatment with a BA [etanercept (ETN), golimumab (GOLI), certolizumab (CTZ), infliximab (IFX), adalimumab (ADA), rituximab (RTX), abatacept (ABA), or tozilizumab (TZL)]. Our primary end point was OI that involved the suspension of the BA. We consider OI when there was a positive culture (for Candida, Aspergillus or Herpes) or compatible symptoms that responded to specific treatment. We also collected secondary variables: sociodemographic (age, sex); clinical (disease duration, types of BA, hospital admission, previous BA). Statistical analysis: We used survival techniques to estimate the incidence of global OI and OI by periods (1st: 98-2002, 2nd:2002-2007, 3rd: 2007-2013), expressed per 1000 patient-year [CI 95%]. The exposure time was defined from the start date of each BA to suspension, loss of follow up or end of study (23/11/2013). We performed Cox regression models (adjusted by age, duration of RA, sex, calendar time and prior BA) to compare the risk of OI between each BA. Results 405 RA patients were included in the study, they started 744 different courses of BA treatment, with a total follow-up of 1,612 patient-years. Of these, 81% were women with a mean age at diagnosis of 52.5±13 years. The most frequently used drug was ADA (32%), followed by ETN (25%), IFX (21%) and RTX (14%). There were 16 OI (6 Candidas, 2 Aspergillus and 8 Herpes Zoster), 40% required hospitalization and two died of disseminated candidiasis. The incidence of OI was 9.9 [6.1-16.2], and tended to increase over time (1st: 5.9 [1.5 to 23.9]; 2nd: 7.7 [2.9 to 20, 6]; and 3rd: 13.1 [7.1 to 24.3]). We only registered OI cases in anti-TNF and RTX, which is the drug with higher incidence (n=3, I: 20.1 [6.4 to 62.4]). We found no statistically significant association between RTX compared with other BA and the development of OI Conclusions The incidence of OI and its evolution over time in real life conditions is described. It seems that OI tend to increase over time and we had two cases with fatal outcome. Doctors using BA should be concerned about this problem and be aware of the optimal methods for the detection and management of OI. We did not find statistical differences in the rate of OI between BA. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.4509
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