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Gabapentin in Improvement of Procedural Sedation and Analgesia in Oncologic Pediatric Patients: A Clinical Trial.

ABSTRACT: Background:Preoperative anxiety and distress can produce significant psychological impacts on children undergoing oncologic care or investigation. Adjuvant therapy is used for pain management in children; however, pre-analgesia options are restricted because they can cause undesirable outcomes. Objectives:Our study aimed to investigate the use of gabapentin in procedural sedation as adjuvant therapy in children undergoing oncologic treatment. Methods:We performed a double-blinded, randomized, clinical trial at Albert Sabin Infant's Hospital in Fortaleza, Brazil. Children aged 1 - 6 years who had myelogram or lumbar puncture (associated or not with intrathecal chemotherapy) received placebo or gabapentin syrups (15 mg/kg and 30 mg/kg) one to two hours before the procedure. Preoperative anxiety was evaluated by the Yale preoperative anxiety scale modified (m-YPAS scale). The pediatric anesthesia emergence delirium (PAED) and children and infants postoperative pain scale (CHIPP) scales were used for emergence delirium and pain intensity measurement, respectively. Results:We evaluated 135 patients. We observed that the gabapentin groups presented lower m-YPAS scores than the placebo group at separation and induction times. Postoperatively, the gabapentin groups had lower PAED and CHIPP scores than the placebo group; however, only had PAED scores clinical relevance. No significant differences were found between the gabapentin groups. Furthermore, children with less than three prior similar procedures were more likely to benefit from gabapentin. Postoperative vomiting was prevented by 30 mg/kg gabapentin. Conclusions:Although gabapentin has little preoperative effects, it ameliorates anxiety before induction, improves anesthetic induction, and reduces the occurrence of emergence delirium and postoperative vomiting up to eight hours after the procedure. Thus, we indicate gabapentin as adjuvant therapy for procedural sedation.

SUBMITTER: Pinto Filho WA

PROVIDER: S-EPMC6935294 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Gabapentin in Improvement of Procedural Sedation and Analgesia in Oncologic Pediatric Patients: A Clinical Trial.

Pinto Filho Washington Aspilicueta WA Silveira Lara de Holanda Juca LHJ Vale Mariana Lima ML Fernandes Claudia Regina CR Gomes Josenilia Alves JA

Anesthesiology and pain medicine 20191028 5

<h4>Background</h4>Preoperative anxiety and distress can produce significant psychological impacts on children undergoing oncologic care or investigation. Adjuvant therapy is used for pain management in children; however, pre-analgesia options are restricted because they can cause undesirable outcomes.<h4>Objectives</h4>Our study aimed to investigate the use of gabapentin in procedural sedation as adjuvant therapy in children undergoing oncologic treatment.<h4>Methods</h4>We performed a double-b ...[more]

PMID: 31903327

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Project description:Procedural sedation and analgesia outside the operating theater have become standard care in managing pain and anxiety in children undergoing diagnostic and therapeutic procedures. The objectives of this study are to describe the current pediatric procedural sedation and analgesia practice patterns in European emergency departments, to perform a needs assessment-like analysis, and to identify barriers to implementation. A survey study of European emergency departments treating children was conducted. Through a lead research coordinator identified through the Research in European Pediatric Emergency Medicine (REPEM) network for each of the participating countries, a 30-question questionnaire was sent, targeting senior physicians at each site. Descriptive statistics were performed. One hundred and seventy-one sites participated, treating approximately 5 million children/year and representing 19 countries, with a response rate of 89%. Of the procedural sedation and analgesia medications, midazolam (100%) and ketamine (91%) were available to most children, whereas propofol (67%), nitrous oxide (56%), intranasal fentanyl (47%), and chloral hydrate (42%) were less frequent. Children were sedated by general pediatricians in 82% of cases. Safety and monitoring guidelines were common (74%), but pre-procedural checklists (51%) and capnography (46%) less available. In 37% of the sites, the entire staff performing procedural sedation and analgesia were certified in pediatric advanced life support. Pediatric emergency medicine was a board-certified specialty in 3/19 countries. Physician (73%) and nursing (72%) shortages and lack of physical space (69%) were commonly reported as barriers to procedural sedation and analgesia. Nurse-directed triage protocols were in place in 52% of the sites, mostly for paracetamol (99%) and ibuprofen (91%). Tissue adhesive for laceration repair was available to 91% of children, while topical anesthetics for intravenous catheterization was available to 55%. Access to child life specialists (13%) and hypnosis (12%) was rare.Conclusion: Procedural sedation and analgesia are prevalent in European emergency departments, but some sedation agents and topical anesthetics are not widely available. Guidelines are common but further safety nets, nurse-directed triage analgesia, and nonpharmacologic support to procedural sedation and analgesia are lacking. Barriers to implementation include availability of sedation agents, staff shortage, and lack of space. What is Known: • Effective and prompt analgesia, anxiolysis, and sedation (PSA) outside the operating theatre have become standard in managing pain and anxiety in children undergoing painful or anxiogenic diagnostic and therapeutic procedures. • We searched PubMed up to September 15, 2020, without any date limits or language restrictions, using different combinations of the MeSH terms "pediatrics," "hypnotics and sedatives," "conscious sedation," and "ambulatory surgical procedures" and the non-MeSH term "procedural sedation" and found no reports describing the current practice of pediatric PSA in Europe. What is New: • This study is, to the best of our knowledge, the first to shed light on the pediatric PSA practice in European EDs and uncovers important gaps in several domains, notably availability of sedation medications and topical anesthetics, safety aspects such as PSA provider training, availability of nonpharmacologic support to PSA, and high impact interventions such as nurse-directed triage analgesia. • Other identified barriers to PSA implementation include staff shortage, control of sedation medications by specialists outside the emergency department, and lack of space.

Project description:BackgroundProcedural sedation and analgesia (PSA) is used to attenuate the pain and distress that may otherwise be experienced during diagnostic and interventional medical or dental procedures. As the risk of adverse events increases with the depth of sedation induced, frequent monitoring of level of consciousness is recommended. Level of consciousness is usually monitored during PSA with clinical observation. Processed electroencephalogram-based depth of anaesthesia (DoA) monitoring devices provide an alternative method to monitor level of consciousness that can be used in addition to clinical observation. However, there is uncertainty as to whether their routine use in PSA would be justified. Rigorous evaluation of the clinical benefits of DoA monitors during PSA, including comprehensive syntheses of the available evidence, is therefore required. One potential clinical benefit of using DoA monitoring during PSA is that the technology could improve patient safety by reducing sedation-related adverse events, such as death or permanent neurological disability. We hypothesise that earlier identification of lapses into deeper than intended levels of sedation using DoA monitoring leads to more effective titration of sedative and analgesic medications, and results in a reduction in the risk of adverse events caused by the consequences of over-sedation, such as hypoxaemia. The primary objective of this review is to determine whether using DoA monitoring during PSA in the hospital setting improves patient safety by reducing the risk of hypoxaemia (defined as an arterial partial pressure of oxygen below 60 mmHg or percentage of haemoglobin that is saturated with oxygen [SpO(2)] less than 90 %). Other potential clinical benefits of using DoA monitoring devices during sedation will be assessed as secondary outcomes.Methods/designElectronic databases will be systematically searched for randomized controlled trials comparing the use of depth of anaesthesia monitoring devices with clinical observation of level of consciousness during PSA. Language restrictions will not be imposed. Screening, study selection and data extraction will be performed by two independent reviewers. Disagreements will be resolved by discussion. Meta-analyses will be performed if suitable.DiscussionThis review will synthesise the evidence on an important potential clinical benefit of DoA monitoring during PSA within hospital settings.Systematic review registrationPROSPERO CRD42015017251.

Project description:BACKGROUND:In women with abnormal uterine bleeding, fibroids are a frequent finding. In case of heavy menstrual bleeding and presence of submucosal type 0-1 fibroids, hysteroscopic resection is the treatment of first choice, as removal of these fibroids is highly effective. Hysteroscopic myomectomy is currently usually performed in the operating theatre. A considerable reduction in costs and a higher patient satisfaction are expected when procedural sedation and analgesia with propofol (PSA) in an outpatient setting is applied. However, both safety and effectiveness - including the necessity for re-intervention due to incomplete resection - have not yet been evaluated. METHODS:This study is a multicentre randomised controlled trial with a non-inferiority design and will be performed in the Netherlands. Women > 18 years with a maximum of 3 symptomatic type 0 or 1 submucosal fibroids with a maximum diameter of 3.5 cm are eligible to participate in the trial. After informed consent, 205 women will be randomised to either hysteroscopic myomectomy using procedural sedation and analgesia with propofol in an outpatient setting or hysteroscopic myomectomy using general anaesthesia in a clinical setting in the operating theatre. Primary outcome will be the percentage of complete resections, based on transvaginal ultrasonography 6 weeks postoperatively. Secondary outcomes are cost effectiveness, menstrual blood loss (Pictorial blood assessment chart), quality of life, pain, return to daily activities/work, hospitalization, (post) operative complications and re-interventions. Women will be followed up to one year after hysteroscopic myomectomy. DISCUSSION:This study may demonstrate comparable effectiveness of hysteroscopic myomectomy under procedural sedation and analgesia versus general anaesthesia in a safe and patient friendly environment, whilst achieving a significant cost reduction. TRIAL REGISTRATION:Dutch trial register, number NTR5357 . Registered 11th of August 2015.

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Gabapentin in Improvement of Procedural Sedation and Analgesia in Oncologic Pediatric Patients: A Clinical Trial.

Publications

Gabapentin in Improvement of Procedural Sedation and Analgesia in Oncologic Pediatric Patients: A Clinical Trial.

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