Dataset Information

Intranasal Midazolam With Lidocaine for Sedation in Pediatric Myringotomy and Tube Surgery: A Randomized Controlled Trial.

ABSTRACT:

Background and aims

Intranasal 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).

Methods

This 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).

Results

Forty-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).

Conclusions

The 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.

SUBMITTER: Ullman DA

PROVIDER: S-EPMC9312809 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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Publications

Intranasal Midazolam With Lidocaine for Sedation in Pediatric Myringotomy and Tube Surgery: A Randomized Controlled Trial.

Ullman David A DA Victory Jennifer M JM Scribani Melissa B MB

Cureus 20220723 7

<h4>Background and aims</h4>Intranasal 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).<h4>Methods</h4>This trial enrolled children aged between 18 months to seven years undergoing BMT, physical status class 1 or 2, in a single ...[more]

PMID: 35910700

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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:PurposeDespite the brevity of the procedure, bilateral myringotomy and tympanostomy tube placement (BMT) can result in significant postoperative pain and discomfort. As the procedure is frequently performed without intravenous access, non-parenteral routes of administration are frequently used for analgesia. The current study prospectively compares the efficacy of intranasal (IN) dexmedetomidine with IN fentanyl for children undergoing BMT.MethodsThis prospective, double-blinded, randomized clinical trial included pediatric patients undergoing BMT. The patients were randomized to receive either IN dexmedetomidine (1 μg/kg) or fentanyl (2 μg/kg) after the induction of general anesthesia with sevoflurane. All patients received rectal acetaminophen (40 mg/kg) and the first 50 patients also received premedication with oral midazolam. Postoperative pain and recovery were assessed using pediatric pain and recovery scales, and any adverse effects were monitored for.ResultsThe study cohort included 100 patients who ranged in age from 1 to 7.7 years and in weight from 8.6 to 37.4 kg. They were divided into 4 groups with 25 patients in each group: (1) midazolam premedication+IN dexmedetomidine; (2) midazolam premedication+IN fentanyl; (3) no premedication+IN dexmedetomidine; and (4) no premedication+IN fentanyl. Pain scores were comparable when comparing groups 2, 3 and 4, but were higher in group 1 (midazolam premedication with IN dexmedetomidine). There was no difference in total time in the post-anesthesia care unit (PACU) or time from arrival in the PACU until hospital discharge between the 4 groups. The heart rate (HR) was significantly lower in group 3 when compared to the other groups at several different times after arrival to the PACU. No clinically significant difference was noted in blood pressure.ConclusionFollowing BMT, when no premedication is administered, there was no clinical advantage when comparing IN dexmedetomidine (1 μg/kg) to IN fentanyl (2 μg/kg). The addition of oral midazolam as a premedication worsened the outcome measures particularly for children receiving IN dexmedetomidine.

Project description:BackgroundIntranasal midazolam and ketamine have been widely used as sedative premedication in children. It is difficult to determine which one yields better sedative effects for clinical practice. We conducted the present meta-analysis by summarizing the evidences to evaluate the efficacy and safety of intranasal midazolam versus intranasal ketamine as sedative premedication in pediatric patients.MethodsWe searched PubMed, Embase, and Cochrane Library from inception to April 2022. All randomized controlled trials (RCTs) used intranasal midazolam and ketamine as sedatives in children were enrolled. The risk of bias in RCTs was assessed by Cochrane risk of bias tool. Condition of parental separation, anesthesia induction or facemask acceptance, sedation level, different hemodynamic parameters and adverse events were considered as the outcomes in our study.ResultsA total of 16 studies with 1066 patients were enrolled. Compared with midazolam, administration of intranasal ketamine might be associated with severer changes in hemodynamics parameters including mean blood pressure (SMD = -0.53, with 95% CI [-0.93, -0.13]) and heart rate (HR) (SMD = -1.39, with 95% CI [-2.84, 0.06]). Meanwhile, administration of intranasal midazolam was associated with more satisfactory sedation level (61.76% vs 40.74%, RR = 1.53, with 95%CI [1.28, 1.83]), more rapid onset of sedation (SMD = -0.59, with 95%CI [-0.90, -0.28]) and more rapid recovery (SMD = -1.06, with 95%CI [-1.83, -0.28]). Current evidences also indicated that the differences of various adverse effects between two groups were not significant.ConclusionsGiven that administration of midazolam via intranasal route provides more satisfactory sedative level with less fluctuation of hemodynamics parameters and more rapid onset and recovery, it might be considered as the preferred sedative premedication for pediatric patients compared to ketamine. However, the widespread evidences with low or moderate quality indicated that superiority of intranasal midazolam in pediatric sedation needs to be confirmed by more studies with high quality and large sample size in future.Trial registrationThe protocol of present study was registered with PROSPERO (CRD42022321348).

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).

Project description:BACKGROUND:Intranasal lidocaine has been shown to be effective in treating patients with acute migraines; however, its efficacy is still controversial. In this study, we intend to assess the efficacy and safety of intranasal lidocaine compared with a placebo or an active comparator for the treatment of migraines. METHOD:PubMed, EMBASE, Cochrane library, and Scopus databases were searched from their inceptions to November 2018. Randomized controlled studies investigating the efficacy of intranasal lidocaine compared with a placebo or an active comparator were selected. Two reviewers independently extracted and synthesized data using a random-effects model. The primary outcome was pain intensity. The secondary outcomes were success rate, the need for rescue medicine, and relapse occurrences. We registered the study at PROSPERO with an ID of CRD42018116226. RESULTS:Six studies (n = 613) were eligible for the meta-analysis. Overall, the results revealed that the study population who was administered intranasal lidocaine had a lower pain intensity at 5 min (standardized mean difference (SMD) = -0.61; 95% CI = -1.04 to -0.19) and 15 min (SMD = -0.72; 95% CI = -1.14 to -0.19), had a higher success rate (RR = 3.55; 95% CI: 1.89 to 6.64) and a less frequent need for rescue medicine (RR = 0.51; 95% CI = 0.36 to 0.72) than the control group. These beneficial effects were not observed when an antiemetic was administered. Furthermore, intranasal lidocaine use had no significant influence on the relapse rate (RR = 0.89; 95% CI = 0.51-1.56), regardless of the use of antiemetics. Using lidocaine caused local irritation in up to 49.4% of the patients in one report but did not cause major adverse events. CONCLUSION:Intranasal lidocaine can be considered a useful option for patients with an acute migraine. It yields a high success rate, a low pain intensity, an infrequent need for rescue medicine, and tolerable adverse events. The administration of antiemetics is an important confounding factor.

Dataset Information

Intranasal Midazolam With Lidocaine for Sedation in Pediatric Myringotomy and Tube Surgery: A Randomized Controlled Trial.

Background and aims

Methods

Results

Conclusions

Publications

Intranasal Midazolam With Lidocaine for Sedation in Pediatric Myringotomy and Tube Surgery: A Randomized Controlled Trial.

Similar Datasets

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