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Success rate of IR midazolam sedation in combination with C-CLAD in pediatric dental patients-a prospective observational study.

ABSTRACT: Objective. To evaluate the success rate of intra-rectal (IR) midazolam in combination with nitrous oxide/oxygen (N2O) sedation in young uncooperative dental patients when the local anesthesia is delivered by a computerized controlled local anesthetic delivery (C-CLAD). Study Design. This observational study consisted of 219 uncooperative children (age: 4.3 ± 1.69 y) who received IR midazolam (0.4 mg/kg) and N2O to complete their dental treatment. Measured variables included: child's pain disruptive behavior during delivery of anesthesia by C-CLAD (CHEOP Scale), child behavior during treatment (Houpt scale), dental procedure performed, and side effects that appeared during treatment. Results. There was a high level of cooperation (mean score: 6.69 ± 2.1) during administration of local anesthesia. Good-to-excellent behavior was shown by 87% of the children during treatment. Planned treatment was completed by 184 (92%) patients. No statistically significant changes were noticed in the oxygen saturation levels before and after treatment. Children with side effects included 3 (1.3%) with nistagmus, 5 (2.3%) with diplopia, and 18 (8.2%) with hiccups. Three consecutive sedations decreased the overall behavior score by 5.7% compared to the first appointment (p < .05). Conclusions. IR midazolam-N2O sedation in combination with C-CLAD is very effective for delivery of dental treatment to young uncooperative children.

SUBMITTER: Ashkenazi M

PROVIDER: S-EPMC3961156 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Success rate of IR midazolam sedation in combination with C-CLAD in pediatric dental patients-a prospective observational study.

Ashkenazi Malka M Baniel Anat A

PeerJ 20140306

Objective. To evaluate the success rate of intra-rectal (IR) midazolam in combination with nitrous oxide/oxygen (N2O) sedation in young uncooperative dental patients when the local anesthesia is delivered by a computerized controlled local anesthetic delivery (C-CLAD). Study Design. This observational study consisted of 219 uncooperative children (age: 4.3 ± 1.69 y) who received IR midazolam (0.4 mg/kg) and N2O to complete their dental treatment. Measured variables included: child's pain disrupt ...[more]

PMID: 24688838

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Project description:BackgroundUncooperative children may need to receive dental treatment under sedation, which is indicated when nonpharmacological behavior guidance is unsuccessful. There are randomized controlled trials (RCTs) comparing different sedative protocols for dental procedures; however, the evidence for superiority of one form over another is weak. The primary aim of this study is to investigate the efficacy of intranasally administered ketamine plus midazolam for the dental treatment of children.MethodsWe have designed a three-armed, parallel RCT to assess intranasal sedation using ketamine/midazolam in terms of the following measures: efficacy, safety, and cost-effectiveness. Two- to 6-year-old healthy children, referred for dental treatment in a dental sedation center in Brazil due to uncooperative behavior and requiring restorative dental procedures, will be recruited. Each child will be randomly assigned to one of the three groups: A - Intranasal administration of ketamine (4.0 mg/kg, maximum 100 mg) and midazolam (0.2 mg/kg, maximum 5.0 mg); B - Oral administration of ketamine (4.0 mg/kg, maximum 100 mg) and midazolam (0.5 mg/kg, maximum 20 mg); and C - Oral administration of midazolam (1.0 mg/kg, maximum 20 mg). The primary outcome is the child's behavior assessed through an observational scale using digital videos of the restorative dental treatment under sedation. The secondary outcomes are as follows: acceptance of sedative administration; memory of intraoperative events; the child's stress; adverse events; the child's pain during the procedure; the parent's, dentists', and child's perceptions of sedation; and economic analysis. Measures will be taken at baseline and drug administration and during and after the dental procedure. The necessary sample size was estimated to be 84 children after a blinded interim analysis of the first 30 cases.DiscussionThis study will provide data that can substantially add to science and pediatric dentistry as it examines the effect of sedative regimes from different perspectives (outcomes).Trial registrationClinicalTrials.gov, identifier: NCT02447289 . Registered on 11 May 2015, named "Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment (NASO)."

Project description:PurposeThe optimal sedative regime that provides the greatest comfort and the lowest risk for procedural sedation in young children remains to be determined. The aim of this randomized, blinded, controlled, parallel-design trial was to evaluate the efficacy of intranasal ketamine and midazolam as the main component of the behavioral guidance approach for preschoolers during dental treatment.Materials and methodsChildren under seven years of age, with caries and non-cooperative behavior, were randomized into three groups: (KMIN) intranasal ketamine and midazolam; (KMO) oral ketamine and midazolam; or (MO) oral midazolam. The dental sedation appointments were videotaped, and the videos were analyzed using the Ohio State University Behavioral Rating Scale (OSUBRS) to determine the success of the sedation in each group. Intra- and postoperative adverse events were recorded. Data analysis involved descriptive statistics and non-parametric tests (P < 0.05, IBM SPSS).ResultsParticipants were 84 children (28 per group; 43 boys), with a mean age of 3.1 years (SD 1.2). Children's baseline and the dental sedation session characteristics were balanced among groups. The success of the treatment as assessed by the dichotomous variable 'quiet behavior for at least 60% of the session length' was: KMIN 50.0% (n = 14; OR 2.10, 95% CI 0.71 to 6.30), KMO 46.4% (n = 13; OR 1.80, 95% CI 0.62 to 5.40), MO 32.1% (n = 9) (P = 0.360). Adverse events were minor, occurred in 37 of 84 children (44.0%), and did not differ among groups (P = 0.462).ConclusionAll three regimens provided moderate dental sedation with minor adverse events, with marked variability in the behavior of children during dental treatment. The potential benefit of the ketamine-midazolam combination should be further investigated in studies with larger samples.Trial registrationClinicalTrials.gov, identifier: NCT02447289. Registered on 11 May 2015, named "Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment (NASO)."

Project description:OBJECTIVES:Outcomes associated with a sedative regimen comprised ketamine + propofol for pediatric procedural sedation outside of both the pediatric emergency department and operating room are underreported. We used the Pediatric Sedation Research Consortium database to describe a multicenter experience with ketamine + propofol by pediatric sedation providers. DESIGN:Prospective observational study of children receiving IV ketamine + propofol for procedural sedation outside of the operating room and emergency department using data abstracted from the Pediatric Sedation Research Consortium during 2007-2015. SETTING:Procedural sedation services from academic, community, free-standing children's hospitals, and pediatric wards within general hospitals. PATIENTS:Children from birth to less than or equal to 21 years old. INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULTS:A total of 7,313 pediatric procedural sedations were performed using IV ketamine + propofol as the primary sedative regimen. Median age was 84 months (range, < 1 mo to ? 21 yr; interquartile range, 36-144); 80.6% were American Society of Anesthesiologists-Physical Status less than III. The majority of sedation was performed in dedicated sedation or radiology units (76.1%). Procedures were successfully completed in 99.8% of patients. Anticholinergics (glycopyrrolate and atropine) or benzodiazepines (midazolam and lorazepam) were used in 14.2% and 41.3%, respectively. The overall adverse event and serious adverse event rates were 9.79% (95% CI, 9.12-10.49%) and 3.47% (95% CI, 3.07-3.92%), respectively. No deaths occurred. Risk factors associated with an increase in odds of adverse event included ASA status greater than or equal to III, dental suite, cardiac catheterization laboratory or radiology/sedation suite location, a primary diagnosis of having a gastrointestinal illness, and the coadministration of an anticholinergic. CONCLUSIONS:Using Pediatric Sedation Research Consortium data, we describe the diverse use of IV ketamine + propofol for procedural sedation in the largest reported cohort of children to date. Data from this study may be used to design sufficiently powered prospective randomized, double-blind studies comparing outcomes of sedation between commonly administered sedative and analgesic medication regimens.

Dataset Information

Success rate of IR midazolam sedation in combination with C-CLAD in pediatric dental patients-a prospective observational study.

Publications

Success rate of IR midazolam sedation in combination with C-CLAD in pediatric dental patients-a prospective observational study.

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