Safety and Efficacy of IV Dexmedetomidine as an Adjunct to Propofol to Sedate Anxious and Uncooperative Pediatric Dental Patients: A Randomized Controlled Trial

Objective : To evaluate the safety and efficacy of dexmedetomidine (dex) as an adjunct to propofol sedation in pediatric dental patients. Study design: This RCT enrolled 30 anxious ASA-I 2-5 year olds. Allocated into 2 groups either receiving IV propofol (1 mg/kg)(Gp-P) or [IV dex (1ug/kg) with propofol(1 mg/kg)] (Gp-D) after oral midazolam premedication (0.5 mg/kg). Sedation maintained with propofol infusion at 50–75ug/kg/min. Additional bolus/es of propofol (1mg/kg) was/were administered in case of inadequate sedation. Primary outcome was to compare requirement of propofol in two groups. Secondary outcomes were to compare vital signs, depth of sedation, induction, treatment and recovery time, intra & post-operative complications and analgesic requirement post-operatively. Results : Total propofol (in mgs) used and number of additional boluses were significantly higher in group P (p<0.05). Although within normal limits, heart rate was significantly lower in group D. Respiratory rate, oxygen saturation, NIBP were comparable. Depth of sedation achieved was comparable at all steps (p>0.05). Induction time (mins) was significantly lower in Group P (p<0.05), however treatment and recovery time were similar (p>0.05). Desaturation was observed in 3/15(group P) & 0/15(group D). Analgesic requirement post-operatively was significantly higher in group P (p<0.05). Conclusion: Dexmedetomidine is a safe and effective adjunct to propofol.

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Olanzapine or chlorpromazine plus lithium in first episode psychotic mania: An 8-week randomised controlled trial

European Psychiatry ◽

10.1016/j.eurpsy.2015.09.009 ◽

2015 ◽

Vol 30 (8) ◽

pp. 975-982 ◽

Cited By ~ 13

Author(s):

P. Conus ◽

M. Berk ◽

S.M. Cotton ◽

L. Kader ◽

C. Macneil ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Safety Profile ◽

Repeated Measures ◽

Controlled Trial ◽

Vital Signs ◽

Treatment Strategies ◽

First Episode ◽

Safety And Efficacy ◽

Randomised Controlled ◽

Over Time

AbstractBackgroundTreatment strategies for mental disorders may vary according to illness stage. However no data currently exist to guide treatment in first episode psychotic mania. The aim of this study was to compare the safety and efficacy profile of chlorpromazine and olanzapine, as add-on to lithium, in patients with a first episode of psychotic mania, expecting better safety profile and adherence to olanzapine but similar efficacy for both treatments.MethodsData from 83 patients were collected in an 8-week randomised controlled trial on clinical variables, side effects, vital signs, and weight. Analyses of treatment differences over time were based on intent-to-treat principles. Kaplan-Meier estimated survival curves were used to analyse time-to-event data and mixed effects models repeated measures analysis of variance were used to determine treatment group differences over time on safety and efficacy measures.ResultsEthics committee approval to delay informed consent procedure until recovery from the acute episode allowed the inclusion of 83 patients highly representative of those treated in the public sector. Contrary to our hypotheses, safety profile of both medications was similar. A signal for higher rate (P=.032) and earlier occurrence (P= .043) of mania remission was observed in the olanzapine group which did not survive correction for multiple comparisons.ConclusionsOlanzapine and chlorpromazine have a similar safety profile in a uniquely representative cohort of patients with first episode psychotic mania. The possibility for a greater impact of olanzapine on manic symptoms leading to earlier remission of the episode needs exploration in a large sample.

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Safety and efficacy of intravenous oxycodone in geriatric patients undergoing general anesthesia for ophthalmic surgeries:a randomized controlled trial

10.21203/rs.2.18971/v1 ◽

2019 ◽

Author(s):

Shuangshuang Li ◽

Dongdong Yao ◽

Xiao Hu ◽

Wenxian Li ◽

Fang Tan

Keyword(s):

Postoperative Pain ◽

General Anesthesia ◽

Recovery Time ◽

Geriatric Patients ◽

Perioperative Complications ◽

Controlled Trial ◽

Rescue Analgesia ◽

Safety And Efficacy ◽

Sedation Level ◽

Vasoactive Medication

Abstract BackgroundThe present study aimed to compare the safety and efficacy of intravenous oxycodone with fentanyl in geriatric patients undergoing general anesthesia for ophthalmic surgeries.Methods107 geriatric patients (age 65-79 years old) with the ASA physical status 1 or 2 undergoing general anesthesia for glaucoma or retina surgeries between May 2016 and November 2017 were divided into three groups: Group O1, Group O2, and Group F. After exclusion, 105 patients were included for the final analysis, with 35 patients in each group. Oxycodone (0.1 mg/kg in Group O1, or 0.2 mg/kg in Group O2) or fentanyl (2 mcg/kg in Group F) was administered intravenously during induction of general anesthesia. Patient demographics, surgical time and anesthesia time, perioperative hemodynamic parameters and requirement of vasoactive medication, postoperative pain and requirement of rescue analgesics, postoperative sedation level and recovery time, and perioperative complications were recorded.ResultsPatients in Group O1 experienced less clinically significant hypotension compared to either Group F or Group O2. Consistently, patients in Group O1 required less intraoperative vasoactive medication (ephedrine) than those in Group F. The postoperative pain on extubation was more severe and more patients required rescue analgesia in Group F compared to Group O2, but not Group O1. The recovery time was longer and sedation level was higher in Group O2 than Group F or O1. The incidence of hypoxia during postoperative recovery was higher in Group O2 than Group F or O1.ConclusionOxycodone at 0.1mg/kg can be a safe and effective application for geriatric patients undergoing general anesthesia for ophthalmic surgeries, with adequate pain control and less side effects.

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Two oral sedation regimens in pediatric dentistry: a randomized controlled trial

Anaesthesia, Pain & Intensive Care ◽

10.35975/apic.v23i4.1170 ◽

2020 ◽

Author(s):

Awj Hammadyeh ◽

Mohamed Altinawi ◽

Faten Rostom

Keyword(s):

Randomized Controlled Trial ◽

Recovery Time ◽

Rating Scale ◽

Controlled Trial ◽

Pediatric Dentistry ◽

Randomized Controlled ◽

Oral Ketamine ◽

Dental Procedures ◽

Oral Sedation ◽

Group D

Objectives: Dental procedures are always associated with some degree of anxiety, and children are usually more prone to it. General anesthesia may have to be used in more complex procedures, but many dental procedures can successfully be undertaken with therapeutic sedation. The aim of this trial was to evaluate the effectiveness of oral sedation using dexmedetomidine in comparison with ketamine in the management of uncooperative pediatric patients during dental treatment. Methodology: A randomized clinical trial was carried out on 40 ASA physical status-I children aged 2-6 y to investigate the effect of using dexmedetomidine and ketamine with atropine for sedation. The children were equally and randomly divided into two groups: Group K: received oral ketamine 5 mg/kg with atropine 0.01 mg/kg, and Group D: received oral dexmedetomidine 3 µg/kg. Recovery time, vital signs, and side effects were all recorded. Behavior rating was also assessed using the Ohio State University Behavioral Rating Scale (OSUBRS). Results: The children in Group D were more sedated than in Group K, but the difference was not statistically significant (p = 0.22). The median recovery time was significantly shorter in Group D than in Group K (p = 0.003). No adverse effects, episodes of respiratory or cardiovascular instability were noted in either groups. Conclusions: Oral dexmedetomidine is equally effective to oral ketamine for sedation in children undergoing outpatient dental procedures, but has relatively a shorter recovery time. Citation: Hammadyeh A, Altinawi M, Rostom F. Two oral sedation regimens in pediatric dentistry: a randomized controlled trial. Anaesth pain & intensive care 2019;23(4)__

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Safety and efficacy of intravenous oxycodone in geriatric patients undergoing general anesthesia for ophthalmic surgeries:a randomized controlled trial

10.21203/rs.2.13244/v1 ◽

2019 ◽

Author(s):

Shuangshuang Li ◽

Dongdong Yao ◽

Xiao Hu ◽

Wenxian Li ◽

Fang Tan

Keyword(s):

Postoperative Pain ◽

General Anesthesia ◽

Recovery Time ◽

Geriatric Patients ◽

Perioperative Complications ◽

Controlled Trial ◽

Rescue Analgesia ◽

Safety And Efficacy ◽

Sedation Level ◽

Vasoactive Medication

Abstract Abstract Background: The present study aimed to compare the safety and efficacy of intravenous oxycodone with fentanyl in geriatric patients undergoing general anesthesia for ophthalmic surgeries. Methods: 107 geriatric patients (age 65-79 years old) with the ASA physical status 1 or 2 undergoing general anesthesia for glaucoma or retina surgeries between May 2016 and November 2017 were divided into three groups: Group O1, Group O2, and Group F. After exclusion, 105 patients were included for the final analysis, with 35 patients in each group. Oxycodone (0.1 mg/kg in Group O1, or 0.2 mg/kg in Group O2) or fentanyl (2 mcg/kg in Group F) was administered intravenously during induction of general anesthesia. Patient demographics, surgical time and anesthesia time, perioperative hemodynamic parameters and requirement of vasoactive medication, postoperative pain and requirement of rescue analgesics, postoperative sedation level and recovery time, and perioperative complications were recorded. Results: Patients in Group O1 experienced less clinically significant hypotension compared to either Group F or Group O2. Consistently, patients in Group O1 required less intraoperative vasoactive medication (ephedrine) than those in Group F. The postoperative pain on extubation was more severe and more patients required rescue analgesia in Group F compared to Group O2, but not Group O1. The recovery time was longer and sedation level was higher in Group O2 than Group F or O1. The incidence of hypoxia during postoperative recovery was higher in Group O2 than Group F or O1. Conclusion: Oxycodone at 0.1mg/kg can be a safe and effective application for geriatric patients undergoing general anesthesia for ophthalmic surgeries, with adequate pain control and less side effects. Trial registration: The study was registered at http://www.chictr.org.cn , Clinical Trial Number: ChiCTR-IPR-16007927. Date of registration: February 15, 2016. Keywords: Oxycodone, Fentanyl, Geriatric, Ophthalmology, General anesthesia

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