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      Low-Dose Fentanyl, Propofol, Midazolam, Ketamine and Lidocaine Combination vs. Regular Dose Propofol and Fentanyl Combination for Deep Sedation Induction; a Randomized Clinical Trial

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          Abstract

          Introduction:

          Need for procedural sedation and analgesia (PSA) is felt in emergency department (ED) more and more each day. This study aimed to compare the effectiveness of low-dose fentanyl, propofol, midazolam, ketamine and lidocaine combination with regular dose of propofol and fentanyl combination for induction of deep sedation.

          Methods:

          In this single-blind clinical trial, candidate patients for sedation and analgesia aged more than 15 and less than 60 years old, with pain score ≥6 were allocated to one of the groups using block randomization and were compared regarding onset of action, recovery time, and probable side effects.

          Results:

          125 patients with the mean age of 37.8 ± 14.3 years were randomly allocated to each group. 100% of the patients in group 1 (5 drugs) and 56.5% of the patients in group 2 (2 drugs) were deeply sedated in the 3 rd minute after injection. The 2 groups were significantly different regarding onset of action (p = 0.440), recovery time (p = 0.018), and treatment failure (p < 0.001).

          Conclusion:

          Low-dose fentanyl, propofol, midazolam, ketamine and lidocaine combination was more successful in induction of deep sedation compared to regular dose of propofol and fentanyl combination. Recovery time was a little longer in this group and both groups were similar regarding drug side effects and effect on vital signs.

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          Most cited references13

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          Practice guidelines for postanesthetic care: an updated report by the American Society of Anesthesiologists Task Force on Postanesthetic Care.

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            Rapid tranquillisation for agitated patients in emergency psychiatric rooms: a randomised trial of midazolam versus haloperidol plus promethazine.

            (2003)
            To compare two widely used drug treatments for people with aggression or agitation due to mental illness. Pragmatic, randomised clinical trial. Three psychiatric emergency rooms in Rio de Janeiro, Brazil. 301 aggressive or agitated people. Open treatment with intramuscular midazolam or intramuscular haloperidol plus promethazine. Patients tranquil or sedated at 20 minutes. patients tranquil or asleep by 40, 60, and 120 minutes; restrained or given extra drugs within 2 hours; severe adverse events; another episode of agitation or aggression; needing extra visits from doctor during first 24 hours; overall antipsychotic load in first 24 hours; and not discharged by two weeks. 151 patients were randomised to midazolam, and 150 to haloperidol-promethazine mix. Follow up for the primary outcome was available for 298 (99%): 134/151 (89%) of patients given midazolam were tranquil or asleep after 20 minutes compared with 101/150 (67%) of those given haloperidol plus promethazine (relative risk 1.32 (95% confidence interval 1.16 to 1.49)). By 40 minutes, midazolam still had a statistically and clinically significant 13% relative advantage (1.13 (1.01 to 1.26)). After 1 hour, about 90% of both groups were tranquil or asleep. One important adverse event occurred in each group: a patient given midazolam had transient respiratory depression, and one given haloperidol-promethazine had a grande mal seizure. Both treatments were effective. Midazolam was more rapidly sedating than haloperidol-promethazine, reducing the time people are exposed to aggression. Adverse effects and resources to deal with them should be considered in the choice of the treatment.
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              Risk reduction in pediatric procedural sedation by application of an American Academy of Pediatrics/American Society of Anesthesiologists process model.

              Guidelines for risk reduction during procedural sedation from the American Academy of Pediatrics (AAP) and the American Society of Anesthesiologists (ASA) rely on expert opinion and consensus. In this article, we tested the hypothesis that application of an AAP/ASA-structured model would reduce the risk of sedation-related adverse events. Prospectively coded sedation records were abstracted by a hospital quality improvement specialist with practical and administrative experience in pediatric sedation. Process variables included notation of nulla per os (NPO) status, performance of a guided risk assessment, assignment of ASA physical status score, obtaining informed consent, generation of a sedation plan, and assessment of sedation level using a quantitative scoring system. Content variables included adherence to AAP NPO guidelines, ASA class, target sedation level, actual sedation level, age, procedure, and drugs used. Complication risk was assessed by logistic regression and Mantel-Haenszel odds ratios (OR). Complications were identified in 40 of 960 records (4.2%). The complication rate was 34 of 895 (3.8%) with planned conscious sedation and 6 of 65 (9.2%) with planned deep sedation ([DS]; OR: 2.6). Complications were reduced by performance of structured risk assessment (OR: 0.10), adherence to all process guidelines (OR: 0), and avoiding actual DS (OR: 0.4). The only drug associated with higher risk was chloral hydrate (OR: 2.1). Failure to adhere to NPO guidelines did not increase risk in this assessment; however, the adverse event rate was 0 if all process guidelines were followed. Presedation assessment reduces complications of DS. Repeated assessment of sedation score reduces the risk of inadvertent DS. The data provide direct evidence that AAP/ASA guidelines can reduce the risk of pediatric procedural sedation.
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                Author and article information

                Journal
                Emerg (Tehran)
                Emerg (Tehran)
                Emerg
                Emergency
                Shahid Beheshti University of Medical Sciences (Tehran, Iran )
                2345-4563
                2345-4571
                2018
                2 October 2018
                : 6
                : 1
                : e57
                Affiliations
                [1 ] Emergency Department, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
                [2 ] Anesthesiology Department, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
                [3 ] Emergency Department, Shahid Rajaee Hospital, Tonekabon, Iran.
                Author notes
                [* ]Corresponding Author: Shahram Shokrzadeh; Emergency Department, Shahid Rajaee Hospital, Imam Khomeini Street, Tonekabon, Iran.
                Article
                emerg-6-e57
                6289150
                30584573
                84a56c81-c7be-4037-bc25-47580aae3af1
                © Copyright (2018) Shahid Beheshti University ofMedical Sciences

                This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0)( https://creativecommons.org/licenses/by-nc/3.0/).

                History
                : August 2018
                : September 2018
                Categories
                Original Article

                clinical trial,deep sedation,emergency service,hospital,ketamine,propofol,analgesia

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