Off-Label Use of Medications in Children Undergoing Sedation and Anesthesia

Smith, Michael C.; Williamson, Julie; Yaster, Myron; Boyd, Geoffrey J. C.; Heitmiller, Eugenie S.

doi:10.1097/sa.0b013e3182911e98

Cited by 11 publications

(12 citation statements)

References 2 publications

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“…Among drugs that act on the nervous system, the highlight was the off-label use of anesthetics and analgesics (ATC level 3). Smith et al (2012) found that the off-label use of medications is a common occurrence in the United States in the care of children undergoing anesthesia and sedation (Smith et al, 2012). The authors acknowledged the challenges of clinical research with drugs in children and associated ethical and legal issues, but stressed that in this clinical setting, off-label use is a more acceptable practice than deprivation of treatment for a neonate.…”

Section: Discussionmentioning

confidence: 99%

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Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital

Gonçalves

Reis

Marçal

et al. 2018

Braz. J. Pharm. Sci.

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This study was designed to investigate the use of off-label and unlicensed drugs in a Neonatal Care Unit (NCU) and to compare the frequency of use of off-label drugs according to the drug regulatory agencies in Brazil (Agência Nacional de Vigilância Sanitária-ANVISA) and the United States Food and Drug Administration (FDA). A prospective observational study was carried out in the NCU. Prescriptions were classified as off-label and unlicensed using both ANVISA and FDA criteria. A total of 157 newborns and 1187 prescriptions were analyzed. The most prescribed drug was fentanyl (9.3%), followed by multivitamin (8.4%) and gentamicin (7.9%). According to ANVISA criteria, there were 665 (56.0%) offlabel prescriptions and 86 (7.2%) unlicensed prescriptions and 95.5% of newborns received at least one drug off-label. By contrast, according to FDA criteria, there were 592 (49.9%) off-label prescriptions and 84 (7.1%) unlicensed prescriptions, and 72.0% of newborns received at least one drug off-label. The offlabel use of drugs registered by ANVISA differed significantly from that of drugs registered by the FDA. There was a high frequency of off-label and unlicensed drug use in the investigated NCU, and there was an inverse relationship between off-label and unlicensed usage and the gestational age of the newborns.

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Section: Discussionmentioning

confidence: 99%

“…The classification of drugs according to the FDA was performed using Drugdex Micromedex TM (Drugdex, 2014). Micromedex TM provides registration data and directions approved by the FDA and this classification was used in research to evaluate the offlabel use of prescription drugs (Smith et al, 2012).…”

Section: Data Collectionmentioning

confidence: 99%

Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital

Gonçalves

Reis

Marçal

et al. 2018

Braz. J. Pharm. Sci.

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“…On the other hand, oxycodone is an active analgesic itself. Although commonly prescribed in children, it is not labeled by the United States Food and Drug Administration for use in pediatric patients and illustrates the widespread off‐label use of this drug in pediatric practice and the urgent need for pediatric labeling to guide practitioners .…”

Section: Discussionmentioning

confidence: 99%

Pain management following major intracranial surgery in pediatric patients: a prospective cohort study in three academic children's hospitals

Maxwell

Buckley

Kudchadkar

et al. 2014

Pediatric Anesthesia

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Introduction Pain management following major intracranial surgery is often limited by a presumed lack of need and a concern that opioids will adversely affect postoperative outcome and interfere with the neurologic examination. Nevertheless, evidence in adults is accumulating that these patients suffer moderate to severe pain and this pain is often under-treated. The purpose of this prospective, clinical observational cohort study was to assess the incidence of pain, prescribed analgesics, methods of analgesic delivery, and patient/parent satisfaction in pediatric patients undergoing cranial surgery at 3 major university children’s hospitals. Methods After obtaining IRB and parental consent (and when applicable, patient assent), children who underwent cranial surgery for cancer, epilepsy, vascular malformations, and craniofacial reconstruction were studied. Neither intraoperative anesthetic management nor postoperative pain management was standardized, but were based on institutional routine. Patients were evaluated daily by a study investigator and by chart review for pain scores using age appropriate, validated tools (FLACC, Faces Pain Scale-Revised, Wong Baker Faces Scale or Self-Report on a 0–10 scale), for patient/parent satisfaction using a subset of the NRC Picker satisfaction tool and in adolescents a modified QoR-40, and for the frequency, mode of administration, and type of analgesic provided. Finally, the incidence of opioid-induced side effects, specifically nausea, vomiting, pruritus, altered level of consciousness, and need for emergency diagnostic radiologic studies for altered neurologic examination were recorded. Data are provided as mean ± SD. Results Two hundred children (98:102 M:F), averaging 7.8 ± 5.8 years old (range 2 mos to 18.5 yr) and 32.2 ± 23.0 kg (range 4.5 to 111.6 kg) undergoing craniectomy (51), craniotomy (96), and craniofacial reconstruction (53) were studied. Despite considerable variation in mode and route of analgesic administration, there were no differences in average pain score, length of hospital stay, or parental satisfaction with care. Interestingly, opioid induced side effects were not related to total daily opioid consumption, site of surgery, or method of opioid delivery. The most common side effect was vomiting. No patient developed respiratory depression or altered mental status secondary to analgesic therapy. Regardless of age or procedure, once eating, most patients were treated with oral oxycodone and/or acetaminophen. Conclusions Despite considerable variation in modality and route of analgesic administration, there were no differences in average pain score, length of stay, or parental satisfaction with care. Pain scores were low, side effects were minimal, and parental satisfaction was high, providing equipoise for future blinded prospective randomized trials in this patient population.

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“…The human brains develop rapidly from the embryonic period to 2 years after birth [6], and are extremely sensitive to anesthetic drugs. Therefore, the pediatric use of propofol in certain age groups remains offlabel [7], despite that the FDA issued a warning on the offlabel use of propofol in children in intensive care units [8].…”

Section: Introductionmentioning

confidence: 99%

Dexmedetomidine reduces propofol-induced apoptosis of neonatal rat hippocampal neurons via up-regulating Bcl-2 expression

Li¹,

Zeng²,

Wang³

et al. 2018

biomedicalresearch

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Background: The use of anesthetics propofol in certain pediatric age groups remains off-label, but it may cause neuronal apoptosis, long-term cognitive and neurological abnormalities during early postnatal period. Dexmedetomidine (Dex) can exert neuroprotective effects in rats. This study aimed to evaluate the effects of Dex and propofol on the apoptosis of neonatal rat hippocampal neurons. Methods: Primary hippocampal neurons of neonatal rats were isolated and identified by immunofluorescence. Neurons were then divided into normal control, propofol (12 μg/ml propofol), and propofol+Dex group (12 μg/ml propofol+0.25 μg/ml Dex). The cell morphology was detected by Hematoxylin-Eosin (HE) staining. The cell apoptosis was analysed by flow cytometry and Hoechst assay. The expression of Bcl-2 mRNA and protein was determined by quantitative reverse transcription PCR and Western blot. Results: The apoptosis rate and proportion of Hoechst-positive cells in propofol group was significantly higher compared with control group (p=0.023 and 0.036, respectively). Propofol+Dex group exhibited significantly lower apoptosis and Hoechst-positive rate compared with propofol group (p=0.016 and 0.028, respectively). The expression of Bcl-2 mRNA and protein in propofol group was significantly decreased compared with control group (p=0.012 and 0.043, respectively). The Bcl-2 mRNA and protein expression in propofol+Dex group was significantly higher than those in propofol group (p=0.033 and 0.026, respectively). Conclusion: Propofol inhibited the growth and induced apoptosis of neonatal rat hippocampal neurons, whereas Dex suppressed the propofol-induced apoptosis via increasing the expression of Bcl-2. Our findings indicate that Dex in conjunction with propofol might reduce the propofol-induced neurotoxicity in pediatric patients who undergo general anesthetics, and therefore might provide an effective clinical measure against neural damages associated with general anesthetics.

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Off-Label Use of Medications in Children Undergoing Sedation and Anesthesia

Cited by 11 publications

References 2 publications

Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital

Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital

Pain management following major intracranial surgery in pediatric patients: a prospective cohort study in three academic children's hospitals

Dexmedetomidine reduces propofol-induced apoptosis of neonatal rat hippocampal neurons via up-regulating Bcl-2 expression

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