Combined sedation in pediatric magnetic resonance imaging: determination of median effective dose of intranasal dexmedetomidine combined with oral midazolam
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SUBMITTER: Xie H
PROVIDER: S-EPMC10960491 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:Background/purposeOptimal sedation management for pediatric dental treatment demands special focus as it's tubeless and shares a same oral space. The study was to evaluate dexmedetomidine compared to midazolam for intranasal premedication in pediatric dental treatment under intravenous deep sedation.Materials and methodsA hundred children aged 3-7 years scheduled for elective dental treatment under intravenous deep sedation anesthesia were enrolled, of whom 50 children (Group D) were intranasally premedicated with 2.0 μg/kg dexmedetomidine and the remaining 50 children (Group M) received traditional 0.2 mg/kg midazolam. Acceptance rate of venipuncture was regarded as the primary endpoint.ResultsThe acceptance rate of venipuncture in Group D and Group M were 76% versus 52%, respectively (P = 0.021). More children in Group M complained about bitter/sour taste than Group D (62% vs. 8%, P < 0.001). Intraoperatively, children in Group M were found to have more choking cough than Group D (30% vs. 9%, P = 0.003), and patients in Group M required more suction (18 [36%] in Group M vs. 4 [8%] in Group D, P = 0.001). There were no significant differences between the groups in the incidences of temporal hypoxemia (SpO2 ≤ 90%), however, two children in Group M experienced hypoxemia over 10 s.ConclusionCompared to the 0.2 mg/kg midazolam, children premedicated with 2.0 μg/kg intranasal dexmedetomidine showed superior venipuncture acceptance, had less intraoperative choking cough and required fewer suction. It seems to be a good alternative to midazolam as premedication for deep sedation in pediatric dental treatment.
| S-EPMC10829544 | biostudies-literature
Project description:Preprocedural preparation of children scheduled for magnetic resonance imaging (MRI) is challenging. This prospective, randomized trial compared intranasal midazolam with intranasal dexmedetomidine as premedication for children scheduled for brain MRI.In total, 60 children, aged 1-8 years, scheduled for elective brain MRI, were randomly assigned to the intranasal dexmedetomidine (1 μg/kg; Group D) or intranasal midazolam (0.2 mg/kg; Group M) group. We compared hemodynamic and respiratory parameters, onset, level, sedation quality, and successful parental separation. All patients received intravenous propofol as an induction and maintenance agent for MRI.No significant differences were observed in demographic, hemodynamic, and respiratory parameters. Group D (14.3 ± 3.4 min [10-20 min]) had a longer time of sedation onset than Group M (8.7 ± 3.7 min [5-15 min]; P < 0.001). The median and mean sedation scores were lower in Group D (3 and 3.7 ± 0.8, respectively) than Group M (4 and 4.3 ± 1.2, respectively; P = 0.055). Group D (80%) had a higher percentage of children achieving satisfactory sedation at the time of induction than did Group M (53.3%; P = 0.0285). Parental separation was successful in 73.3% of patients in Group D compared with 46.7% of patients in Group M (P = 0.035).Intranasal dexmedetomidine results in more successful parental separation and yields a higher sedation level at the time of induction of anesthesia than intranasal midazolam as premedication, with negligible side effects. However, its onset of action is relatively prolonged.
| S-EPMC5520599 | biostudies-other
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)."
| S-EPMC6411109 | biostudies-literature
Project description:Background and aimsIntranasal midazolam (INM) sedation for children has been associated with side effects. This prospective, double-blind, placebo-controlled trial assessed whether the addition of lidocaine to INM (INM+L) affected efficacy or discharge time among pediatric patients undergoing elective bilateral myringotomy and tube placement (BMT).MethodsThis trial enrolled children aged between 18 months to seven years undergoing BMT, physical status class 1 or 2, in a single academic medical center. Interventions were placebo (intranasal saline), INM only (0.2mg/kg of INM concentration 5mg/ml), and INM+L (0.2mg/kg INM with addition of lidocaine 4% based on 25% of midazolam volume). Outcomes included post-anesthesia care unit times, observed behavioral distress (OBD) visual analog scale (VAS) (by nurse and parent), and sedation scores by certified registered nurse anesthetist (CRNA) and registered nurse (RN).ResultsForty-two subjects were included, 14 in each group, with 52% female, 41% physical status 2, and an average age of 2.7 years. Post-anesthesia care unit times averaged 36.5 minutes (range 15-132 minutes), with no delay in discharge with INM or INM+L versus placebo (p=0.88). Verbal complaints were highest among INM+L at the time of administration (p=0.01). RN-scored OBD at one minute post administration differed significantly across the three groups (p=0.01). Parental OBD scores did not differ across treatment groups. Agitation was greatest at time of induction of anesthesia in the placebo group (p=0.01).ConclusionsThe addition of licodaine to INM does not adversely influence time to discharge and does not reduce side effects, improve efficacy, or change duration of action of INM.
| S-EPMC9312809 | biostudies-literature
Project description:Background and Purpose: Premedication with either oral midazolam or intranasal dexmedetomidine prior to surgery remains less than ideal. The aim of this study was to investigate whether the combination of those two drug regimens would have any beneficial effects on the preoperative sedation and the children's compliance during anesthesia inhalation induction. Experimental Approach: One hundred thirty-eight children aged 2-6 years were randomly allocated into three groups: Group M with oral midazolam 0.5 mg kg-1, Group D with intranasal dexmedetomidine 2 μg kg-1, and Group M + D with intranasal dexmedetomidine 1 μg kg-1 plus oral midazolam 0.5 mg kg-1. The primary outcome was the children's compliance during inhalation induction with sevoflurane. The secondary outcomes included the preoperative sedative effects, behavior scores, parental separation anxiety scores, and the postoperative incidence of emergence agitation and recovery time. Results: Subjects in Group M + D showed higher satisfaction scores of compliance (p = 0.0049) and mask acceptance (MAS) (p = 0.0049) during anesthesia inhalation induction. Subjects in Group M + D had a significantly shorter time than those in Groups M and D to achieve the desired sedation level (p < 0.001) and remained at a higher sedation score in the holding area and up to the anesthesia induction after drug administration (p < 0.001). Conclusion and Implications: We conclude that pediatric patients premedicated with intranasal dexmedetomidine 1 μg kg-1 plus oral midazolam 0.5 mg kg-1 had significantly improved anesthesia induction compliance, and quicker onset to achieve and maintain a satisfactory level of sedation than those premedicated separately with two drugs. Therefore, the combined premed regimen is a greater choice when we are expecting a higher quality of sedation and a smoother anesthesia induction in children undergoing the surgeries.
| S-EPMC8714926 | biostudies-literature
Project description:Breast lumpectomy is usually performed under general or local anesthesia. To the best of our knowledge, whether conscious sedation with intranasal dexmedetomidine and local anesthesia is an effective anesthetic technique has not been studied. Thus, the present study aimed to investigate the effectiveness of conscious sedation with intranasal dexmedetomidine combined with local anesthesia in breast lumpectomy, and to identify its optimal dose. A prospective randomized, double-blinded, placebo-controlled, single-center study was designed, and patients undergoing breast lumpectomies were recruited based on the inclusion and exclusion criteria. All patients were randomly allocated to four groups: i) Local anesthesia with 0.9% intranasal saline (placebo); local anesthesia with ii) 1 µg.kg-1; iii) 1.5 µg.kg-1; or iv) 2 µg.kg-1 intranasal dexmedetomidine. The sedation status, pain relief, vital signs, adverse events, and satisfaction of patient and surgeon were recorded. Patients in the three dexmedetomidine groups were significantly more sedated and experienced less pain compared with the placebo group 45 min after intranasal dexmedetomidine administration and during 30 min in the post-anesthesia care unit. Patients in the 1.5 µg.kg-1 group were more sedated compared with the 1 µg.kg-1 group (without reaching statistical significance), whereas the 1.5 µg.kg-1 group exhibited a similar level of sedation 45 min after intranasal dexmedetomidine administration compared with the 2 µg.kg-1 group. In addition, patients in the 1 and 1.5 µg.kg-1 group experienced no adverse hemodynamic effects. Patient and surgeon satisfaction were greater in the 1.5 µg.kg-1 group compared with the 1 and 2 µg.kg-1 groups. Taken together, the results of the present study suggested that conscious sedation with intranasal dexmedetomidine and local anesthesia may be an effective anesthetic for breast lumpectomy surgery, and that the optimal dose for intranasal dexmedetomidine administration may be 1.5 µg.kg-1, as it resulted in good sedation and patient satisfaction without adverse effects.
| S-EPMC7436885 | biostudies-literature
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)."
| S-EPMC5387269 | biostudies-literature
Project description:BackgroundMidazolam and α2-adrenoceptor agonists have been widely used off-label as intranasal sedatives for children. The present meta-analysis aimed to evaluate the effects of two interventions in pediatric sedation.MethodsPubMed, Embase, and Cochrane Library were searched from inception to April 2022. All randomized controlled trials used intranasal α2-adrenoceptor agonists and midazolam as sedatives in children were enrolled. Parental separation, anesthesia induction or facemask acceptance, sedation level, different hemodynamic parameters and adverse events were considered as outcomes.ResultsTotally 21 studies with 1,495 patients were included. Only one study reported comparison between midazolam and clonidine met the inclusion criteria, and patients in clonidine group had significantly better mask acceptance compared to midazolam group. Compared with midazolam, using of dexmedetomidine was associated with higher rate of satisfactory parental separation (52.88% vs 75.18%, RR = 0.70, with 95%CI [0.55, 0.90]), anesthesia induction or facemask acceptance (60.92% vs 81.47%, RR = 0.76, 95% CI [0.68, 0.84]) and less incidence of postoperative pain and nasal irritation.ConclusionCompared with midazolam, dexmedetomidine should be considered as the preferred intranasal sedative option for pediatric patients, since it provides more satisfactory sedative level with less incidence of several side effects. But insufficient evidences about effects of intranasal clonidine and overall low and moderate quality evidences evaluated by GRADE system indicate that superiority of intranasal α2-adrenoceptor agonists in pediatric sedation needs to be validated by more studies with high quality and large sample size in future.
| S-EPMC9928077 | biostudies-literature
Project description:ObjectiveWe compare the efficacy of intranasal dexmedetomidine (DEX) and DEX-esketamine sedation on pediatric acceptance of face mask.MethodsThis single-center double-blind randomized controlled study was conducted at a tertiary hospital affiliated with Shanghai Jiao Tong University. Ninety children aged 1 year to 6 years old and scheduled for elective surgery were randomly allocated in a 1:1 ratio into receiving DEX alone (n = 45) and DEX-esketamine (n = 45). DEX and esketamine were used intranasally at doses of 2 µg/kg and 2.0 mg/kg respectively. Children were assessed by an attending anesthesiologist with modified observer's assessment of alertness and sedation (MOAA/S), pediatric separation anxiety scale (PSAS) and mask acceptance scale (MAS). Perioperative adverse events (bradycardia, hypotension, hypoxia, emergence delirium etc.) were recorded.ResultsOf 95 patients enrolled, 90 completed the study. The proportion of children who accepted facemask was significantly higher in the DEX-esketamine group compared to the DEX group (86.7% (39/45) vs. 62.2% (28/45), p = 0.008). Within 30 min after intranasal administration of agents, PSAS scores were similar between the two groups. Children in the DEX group were easily aroused when repositioned from the transferring bed to the operation table. In contrast, those in the DEX-esketamine group maintained a stable level of sedation (MOAA/S scores, median [25th- 75th interquartile range], 1 [1, 1] for DEX-esketamine vs. 2 [1, 4] for DEX, p < 0.001). Furthermore, subgroup analysis found that DEX-esketamine provided better facemask acceptance in children with high anxiety (PSAS ≥ 3). There were no significant differences in perioperative heart rate, noninvasive blood pressure and percutaneous arterial oxygen saturation between the two groups. Postoperative extubation time and perioperative adverse events were also comparable between the groups (all p > 0.05).ConclusionsFor preoperative sedation, combination of DEX with esketamine improved mask acceptance than dexmedetomidine alone, likely due to its superior anxiolytic effect in children with high anxiety.Trial registrationThis study was registered in the Chinese Clinical Trial Register (registration no. ChiCTR2400087873, registration date on 6/8/2024).
| S-EPMC11817246 | biostudies-literature
Project description:BackgroundChildren under 6 years who need magnetic resonance imaging usually require sedation to obtain best quality images, but the optimal sedation protocol remains to be determined. In 2018, we showed a 22% interruption in image acquisition during magnetic resonance imaging when performing a propofol-based sedation using a bolus approach. As non-pharmacological premedication is often insufficient to reduce the anxiety of children related to parental separation, pharmacological premedication may be useful to facilitate the induction of anesthesia. In our institution, effective premedication is obtained oral intake of midazolam, though its administration relies on patients' compliance and could also lead to paradoxical reaction. Dexmedetomidine has a safe profile in the pediatric population and can therefore represent an interesting alternative. The primary objective of this trial is to demonstrate the superiority of intranasal dexmedetomidine compared to oral midazolam as premedication in reducing the occurrence of any event requiring temporary or definitive interruption of the examination to allow anesthesiologist intervention in children undergoing magnetic resonance imaging under propofol sedation.MethodsIn this single-center, prospective, randomized, double-blind, double-dummy, active comparator-controlled, superiority trial, we planned to include 250 patients, aged 6 months to 6 years, undergoing a scheduled magnetic resonance imaging requiring the presence of an anesthesiologist. After informed consent, the patients will be randomized to receive either oral midazolam or intranasal dexmedetomidine as premedication. The data will be analyzed in intention to treat, using Kolmogorov-Smirnov Z, chi-square, Wilcoxon, and Mann-Whitney U tests. A P-value < 0.05 will be considered statistically significant.DiscussionThe MIDEX MRI study will assess the efficacy of intranasal dexmedetomidine compared to oral midazolam to improve the quality of a propofol-based sedation prior to magnetic resonance imaging, without negative repercussion on the postoperative period.Trial registrationClinicalTrial.gov NCT05192629 . Registered on 14 January 2022. Protocol version 2.1.
| S-EPMC10422697 | biostudies-literature