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Systematic Reviews Mar 2021Midazolam is used for sedation before diagnostic and therapeutic medical procedures by several routes including oral, intravenous, intranasal and intramuscular. This is... (Review)
Review
BACKGROUND
Midazolam is used for sedation before diagnostic and therapeutic medical procedures by several routes including oral, intravenous, intranasal and intramuscular. This is an update of a Cochrane review published in 2016, which aimed to determine the evidence on the effectiveness of midazolam for sedation when administered before a diagnostic or therapeutic procedure in adults and children.
METHODS
We searched CENTRAL, MEDLINE, Embase and two trials registers up to May 2020 together with reference checking to identify additional studies. We imposed no language restrictions. Randomized controlled trials of midazolam in comparison with placebo or other medications used for sedation were included. Two authors independently extracted data and assessed risk of bias for each included study.
RESULTS
Eight new trials were included in this update, which resulted in changed conclusions for the intravenous midazolam versus placebo, oral midazolam versus chloral hydrate and oral midazolam versus placebo comparisons. Effect estimates for all outcomes within the intravenous midazolam versus placebo (7 trials; 633 adults and 32 children) are uncertain due to concerns about imprecision and risk of bias. Midazolam resulted in a higher level of sedation than placebo (mean difference (MD) 1.05; 95% confidence interval (95% CI) 0.69 to 1.41; 1 study; 100 adults). There was no difference in anxiety (RR 0.43, 95% CI 0.09 to 1.99; I = 75%; 2 studies; 123 adults). Risk of difficulty performing procedures was lower in the midazolam group (RR 0.5; 95% CI 0.29 to 0.86; I = 45%; 3 studies; 191 adults and 32 children). There was no difference in discomfort (RR 0.51; 95% CI 0.25 to 1.04; I = 0%; 2 studies; 190 adults). Five trials with 336 children were included in the oral midazolam versus chloral hydrate comparison. Midazolam was less likely to result in moderate sedation (RR 0.30, 95% CI 0.11 to 0.82; I = 64%; 2 studies, 228 participants). This effect estimate is highly uncertain due to concerns about the risk of bias, imprecision and inconsistency. There was no difference in ratings of anxiety (SMD - 0.26; 95% CI - 0.75 to 0.23; I = 0%; 2 studies; 68 participants). Midazolam increased risk of incomplete procedures (RR 4.01; 95% CI 1.92 to 8.40; I = 0%; 4 studies, 268 participants). This effect estimate is uncertain due to concerns about the risk of bias. There were four trials with 359 adults and 77 children included in the oral midazolam versus placebo comparison. Midazolam reduced ratings of anxiety (SMD - 1.01; 95% CI - 1.86 to - 0.16; I = 92%; 4 studies; 436 participants). It is unclear if midazolam has an effect on difficulty performing procedures. Meta-analysis was not performed because there was only one incomplete procedure in the midazolam group in one of the trials. Midazolam reduced pain in one study with 99 adults (MD - 2; 95% CI - 2.5 to - 1.6; moderate quality). The effect estimate is uncertain due to concerns about the risk of bias.
CONCLUSION
The additional evidence arising from inclusion of new studies in this updated review has not produced sufficient high-quality evidence to determine whether midazolam produces more effective sedation than other medications or placebo in any specific population included in this review. For adults, there was low-quality evidence that intravenous midazolam did not reduce the risk of anxiety or discomfort/pain in comparison to placebo, but the sedation level was higher. By combining results from adults and children, there was low-quality evidence of a large reduction in the risk of procedures being difficult to perform with midazolam in comparison to placebo. The effect estimates for this comparison are uncertain because there was concern about risk of bias and imprecision. There is moderate-quality evidence suggesting that oral midazolam produces less-effective sedation than chloral hydrate for completion of procedures for children undergoing non-invasive diagnostic procedures. Ratings of anxiety were not different between oral midazolam and chloral hydrate. The extent to which giving oral midazolam to adults or children decreases anxiety during procedures compared with placebo is uncertain due to concerns about risk of bias and imprecision. There was moderate-quality evidence from one study that oral midazolam reduced the severity of discomfort/pain for adults during a brief diagnostic procedure in comparison with placebo.
Topics: Administration, Intranasal; Adult; Anxiety; Child; Chloral Hydrate; Humans; Midazolam
PubMed: 33673878
DOI: 10.1186/s13643-021-01617-5 -
Frontiers in Medicine 2021The aim of this systematic review and meta-analysis was to investigate the efficacy and safety of remimazolam in clinical endoscopic procedure sedation. The authors...
The aim of this systematic review and meta-analysis was to investigate the efficacy and safety of remimazolam in clinical endoscopic procedure sedation. The authors searched the databases of PubMed, Embase, and Cochrane Library for studies published until January 2, 2021, that reported remimazolam sedation for endoscopic procedures. The sedative efficiency and the incidence of adverse events were assessed as outcomes. Cochrane Review Manager Software 5.3 was used to perform the statistical analyses. Seven relevant studies involving a total of 1,996 patients were identified. We conducted a meta-analysis of the different controls used in the studies, that is, the placebo, midazolam, and propofol. The results demonstrated that remimazolam had a strong sedative effect, and its sedative efficiency was significantly higher than that of placebo [OR = 0.01, 95% CI: (0.00, 0.10), = 30%, <0.00001]. The sedative efficiency of remimazolam was significantly higher than that of midazolam [OR = 0.12, 95% CI: (0.08, 0.21), = 0%, < 0.00001] but lesser than that of propofol [OR = 12.22, 95% CI: (1.58, 94.47), = 0%, = 0.02]. Regarding the adverse events, remimazolam is associated with a lower incidence of hypotension than placebo and midazolam. Similarly, remimazolam was associated with a lower incidence of hypotension and hypoxemia than propofol. Remimazolam is a safe and effective sedative for patients undergoing endoscopic procedures. The sedative efficiency of remimazolam was significantly higher than that of midazolam but slightly lower than that of propofol. However, the respiration and circulation inhibitory effects of remimazolam were weaker than those of midazolam and propofol.
PubMed: 34381792
DOI: 10.3389/fmed.2021.655042 -
Medicine Sep 2018Propofol and midazolam are widely used for the sedation of bronchoscopy. This systematic review and meta-analysis is conducted to compare the efficacy of propofol and... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Propofol and midazolam are widely used for the sedation of bronchoscopy. This systematic review and meta-analysis is conducted to compare the efficacy of propofol and midazolam for bronchoscopy.
METHODS
The databases including PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases are systematically searched for collecting the randomized controlled trials (RCTs) regarding the efficacy of propofol and midazolam for bronchoscopy.
RESULTS
This meta-analysis has included 4 RCTs. Compared with midazolam intervention in patients undergoing bronchoscopy, propofol intervention is associated with remarkably reduced recovery time [standard mean difference (SMD) = -0.74; 95% confidence interval (95% CI) = -1.04 to -0.45; P < .00001], but demonstrates no significant impact on operation time (SMD = -0.01; 95% CI = -0.16 to 0.13; P = .87), induction time (SMD = -0.58; 95% CI = -1.19 to 0.03; P = .06), lowest oxyhemoglobin saturation (SpO2, SMD = 0.24; 95% CI = -0.09 to 0.58; P = .15), SpO2 <90% [risk ratio (RR) = 1.02; 95% CI = 0.82-1.25; P = .88), and major arrhythmias (RR = 0.56; 95% CI = 0.26-1.19; P = .13).
CONCLUSION
Propofol sedation is able to reduce recovery time and shows similar safety compared with midazolam sedation during bronchoscopy.
Topics: Anesthetics, Intravenous; Bronchoscopy; Humans; Hypnotics and Sedatives; Midazolam; Pain, Procedural; Propofol; Randomized Controlled Trials as Topic
PubMed: 30200147
DOI: 10.1097/MD.0000000000012229 -
Archives of Disease in Childhood Jan 2015To determine the extent of inter-individual variation in clearance of midazolam in children and establish which factors are responsible for this variation. (Review)
Review
OBJECTIVES
To determine the extent of inter-individual variation in clearance of midazolam in children and establish which factors are responsible for this variation.
METHODS
A systematic literature review was performed to identify papers describing the clearance of midazolam in children. The following databases were searched: Medline, Embase, International Pharmaceutical Abstracts, CINAHL and Cochrane Library. From the papers, the range in plasma clearance and the coefficient of variation (CV) in plasma clearance were determined.
RESULTS
25 articles were identified. Only 13 studies gave the full range of clearance values for individual patients. The CV was greater in critically ill patients (18%-170%) than non-critically ill patients (13%-54%). Inter-individual variation was a major problem in all age groups of critically ill patients. The CV was 72%-106% in preterm neonates, 18%-73% in term neonates, 31%-130% in infants, 21%-170% in children and 47%-150% in adolescents. The mean clearance was higher in children (1.1-16.7 mL/min/kg) than in neonates (0.78-2.5 mL/min/kg).
CONCLUSIONS
Large inter-individual variation was seen in midazolam clearance values in critically ill neonates, infants, children and adolescents.
Topics: Adolescent; Child; Critical Illness; Humans; Hypnotics and Sedatives; Infant; Infant, Newborn; Metabolic Clearance Rate; Midazolam
PubMed: 25281734
DOI: 10.1136/archdischild-2013-305720 -
BMC Anesthesiology Jun 2024Dexmedetomidine and midazolam are commonly used sedatives in children. We conducted a systematic review and meta-analysis to compare the safety and effectiveness of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Dexmedetomidine and midazolam are commonly used sedatives in children. We conducted a systematic review and meta-analysis to compare the safety and effectiveness of sedation provided by dexmedetomidine combined with midazolam versus other sedatives including chloral hydrate, midazolam and other sedatives in pediatric sedation.
METHODS
The Embase, Web of Science, Cochrane Library, and PubMed databases, and Clinicaltrials.gov register of controlled trials were searched from inception to June 2022. All randomized controlled trials used dexmedetomidine-midazolam in pediatric sedation were enrolled. The articles search, data extraction, and quality assessment of included studies were performed independently by two researchers. The success rate of sedation was considered as the primary outcome. The secondary outcomes included onset time of sedation, recovery time of sedation and occurrence of adverse events.
RESULTS
A total of 522 studies were screened and 6 RCTs were identified; 859 patients were analyzed. The administration of dexmedetomidine combined with midazolam was associated with a higher sedation success rate and a lower incidence of nausea and vomiting in computed tomography, magnetic resonance imaging, Auditory Brainstem Response test or fiberoptic bronchoscopy examinations than the other sedatives did (OR = 2.92; 95% CI: 1.39-6.13, P = 0.005, I = 51%; OR = 0.23, 95% CI: 0.07-0.68, P = 0.008, I = 0%, respectively). Two groups did not differ significantly in recovery time and the occurrence of adverse reactions (WMD = - 0.27, 95% CI: - 0.93 to - 0.39, P = 0.42; OR 0.70; 95% CI: 0.48-1.02, P = 0.06, I = 45%. respectively). However, the results of the subgroup analysis of ASA I-II children showed a quicker onset time in dexmedetomidine-midazolam group than the other sedatives (WMD=-3.08; 95% CI: -4.66 to - 1.49, P = 0.0001, I = 30%).
CONCLUSIONS
This meta-analysis showed that compared with the control group, dexmedetomidine combined with midazolam group provided higher sedation success rates and caused a lower incidence of nausea and vomiting in completing examinations, indicating a prospective outpatient clinical application for procedural sedation.
Topics: Dexmedetomidine; Humans; Hypnotics and Sedatives; Midazolam; Child; Drug Therapy, Combination; Randomized Controlled Trials as Topic
PubMed: 38907338
DOI: 10.1186/s12871-024-02570-1 -
Journal of Pain and Symptom Management Apr 2015Palliative sedation therapy (PST) is increasingly used in patients at the end of life. However, consensus about medications and monitoring is lacking. (Review)
Review
CONTEXT
Palliative sedation therapy (PST) is increasingly used in patients at the end of life. However, consensus about medications and monitoring is lacking.
OBJECTIVES
To assess published PST guidelines with regard to quality and recommendations on drugs and monitoring.
METHODS
We searched CINAHL, the Cochrane Library, Embase, PsycINFO, PubMed, and references of included articles until July 2014. Search terms included "palliative sedation" or "sedation" and "guideline" or "policy" or "framework." Guideline selection was based on English or German publications that included a PST guideline. Two investigators independently assessed the quality of the guidelines according to the Appraisal of Guidelines for Research and Evaluation II instrument (AGREE II) and extracted information on drug selection and monitoring.
RESULTS
Nine guidelines were eligible. Eight guidelines received high quality scores for the domain "scope and purpose" (median 69%, range 28-83%), whereas in the other domains the guidelines' quality differed considerably. The majority of guidelines suggest midazolam as drug of first choice. Recommendations on dosage and alternatives vary. The guidelines' recommendations regarding monitoring of PST show wide variation in the number and details of outcome parameters and methods of assessment.
CONCLUSION
The published guidelines on PST vary considerably regarding their quality and content on drugs and monitoring. Given the need for clear guidance regarding PST in patients at the end of life, this comparative analysis may serve as a starting point for further improvement.
Topics: Guidelines as Topic; Humans; Hypnotics and Sedatives; Monitoring, Physiologic; Palliative Care; Quality Assurance, Health Care
PubMed: 25242022
DOI: 10.1016/j.jpainsymman.2014.08.013 -
British Journal of Clinical Pharmacology Oct 2017Aprepitant and fosaprepitant, commonly used for the prevention of chemotherapy-induced nausea and vomiting, alter cytochrome P450 activity. This systematic review... (Meta-Analysis)
Meta-Analysis Review
AIMS
Aprepitant and fosaprepitant, commonly used for the prevention of chemotherapy-induced nausea and vomiting, alter cytochrome P450 activity. This systematic review evaluates clinically significant pharmacokinetic drug interactions with aprepitant and fosaprepitant and describes adverse events ascribed to drug interactions with aprepitant or fosaprepitant.
METHODS
We systematically reviewed the literature to September 11, 2016, to identify articles evaluating drug interactions involving aprepitant/fosaprepitant. The clinical significance of each reported pharmacokinetic drug interaction was evaluated based on the United States Food and Drug Administration guidance document on conducting drug interaction studies. The probability of an adverse event reported in case reports being due to a drug interaction with aprepitant/fosaprepitant was determined using the Drug Interaction Probability Scale.
RESULTS
A total of 4377 publications were identified. Of these, 64 met inclusion eligibility criteria: 34 described pharmacokinetic drug interactions and 30 described adverse events ascribed to a drug interaction. Clinically significant pharmacokinetic interactions between aprepitant/fosaprepitant and bosutinib PO, cabazitaxel IV, cyclophosphamide IV, dexamethasone PO, methylprednisolone IV, midazolam PO/IV, oxycodone PO and tolbutamide PO were identified, as were adverse events resulting from an interaction between aprepitant/fosaprepitant and alcohol, anthracyclines, ifosfamide, oxycodone, quetiapine, selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors and warfarin.
CONCLUSIONS
The potential for a drug interaction with aprepitant and fosaprepitant should be considered when selecting antiemetic therapy.
Topics: Antiemetics; Antineoplastic Agents; Aprepitant; Cytochrome P-450 CYP2C9 Inducers; Cytochrome P-450 CYP3A Inhibitors; Drug Interactions; Ethanol; Humans; Injection Site Reaction; Morpholines; Nausea; Oxycodone; Quetiapine Fumarate; Selective Serotonin Reuptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors; Vomiting
PubMed: 28470980
DOI: 10.1111/bcp.13322 -
The Cochrane Database of Systematic... May 2016Midazolam is used for sedation before diagnostic and therapeutic medical procedures. It is an imidazole benzodiazepine that has depressant effects on the central nervous... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Midazolam is used for sedation before diagnostic and therapeutic medical procedures. It is an imidazole benzodiazepine that has depressant effects on the central nervous system (CNS) with rapid onset of action and few adverse effects. The drug can be administered by several routes including oral, intravenous, intranasal and intramuscular.
OBJECTIVES
To determine the evidence on the effectiveness of midazolam for sedation when administered before a procedure (diagnostic or therapeutic).
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL to January 2016), MEDLINE in Ovid (1966 to January 2016) and Ovid EMBASE (1980 to January 2016). We imposed no language restrictions.
SELECTION CRITERIA
Randomized controlled trials in which midazolam, administered to participants of any age, by any route, at any dose or any time before any procedure (apart from dental procedures), was compared with placebo or other medications including sedatives and analgesics.
DATA COLLECTION AND ANALYSIS
Two authors extracted data and assessed risk of bias for each included study. We performed a separate analysis for each different drug comparison.
MAIN RESULTS
We included 30 trials (2319 participants) of midazolam for gastrointestinal endoscopy (16 trials), bronchoscopy (3), diagnostic imaging (5), cardioversion (1), minor plastic surgery (1), lumbar puncture (1), suturing (2) and Kirschner wire removal (1). Comparisons were: intravenous diazepam (14), placebo (5) etomidate (1) fentanyl (1), flunitrazepam (1) and propofol (1); oral chloral hydrate (4), diazepam (2), diazepam and clonidine (1); ketamine (1) and placebo (3); and intranasal placebo (2). There was a high risk of bias due to inadequate reporting about randomization (75% of trials). Effect estimates were imprecise due to small sample sizes. None of the trials reported on allergic or anaphylactoid reactions. Intravenous midazolam versus diazepam (14 trials; 1069 participants)There was no difference in anxiety (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.39 to 1.62; 175 participants; 2 trials) or discomfort/pain (RR 0.60, 95% CI 0.24 to 1.49; 415 participants; 5 trials; I² = 67%). Midazolam produced greater anterograde amnesia (RR 0.45; 95% CI 0.30 to 0.66; 587 participants; 9 trials; low-quality evidence). Intravenous midazolam versus placebo (5 trials; 493 participants)One trial reported that fewer participants who received midazolam were anxious (3/47 versus 15/35; low-quality evidence). There was no difference in discomfort/pain identified in a further trial (3/85 in midazolam group; 4/82 in placebo group; P = 0.876; very low-quality evidence). Oral midazolam versus chloral hydrate (4 trials; 268 participants)Midazolam increased the risk of incomplete procedures (RR 4.01; 95% CI 1.92 to 8.40; moderate-quality evidence). Oral midazolam versus placebo (3 trials; 176 participants)Midazolam reduced pain (midazolam mean 2.56 (standard deviation (SD) 0.49); placebo mean 4.62 (SD 1.49); P < 0.005) and anxiety (midazolam mean 1.52 (SD 0.3); placebo mean 3.97 (SD 0.44); P < 0.0001) in one trial with 99 participants. Two other trials did not find a difference in numerical rating of anxiety (mean 1.7 (SD 2.4) for 20 participants randomized to midazolam; mean 2.6 (SD 2.9) for 22 participants randomized to placebo; P = 0.216; mean Spielberger's Trait Anxiety Inventory score 47.56 (SD 11.68) in the midazolam group; mean 52.78 (SD 9.61) in placebo group; P > 0.05). Intranasal midazolam versus placebo (2 trials; 149 participants)Midazolam induced sedation (midazolam mean 3.15 (SD 0.36); placebo mean 2.56 (SD 0.64); P < 0.001) and reduced the numerical rating of anxiety in one trial with 54 participants (midazolam mean 17.3 (SD 18.58); placebo mean 49.3 (SD 29.46); P < 0.001). There was no difference in meta-analysis of results from both trials for risk of incomplete procedures (RR 0.14, 95% CI 0.02 to 1.12; downgraded to low-quality evidence).
AUTHORS' CONCLUSIONS
We found no high-quality evidence to determine if midazolam, when administered as the sole sedative agent prior to a procedure, produces more or less effective sedation than placebo or other medications. There is low-quality evidence that intravenous midazolam reduced anxiety when compared with placebo. There is inconsistent evidence that oral midazolam decreased anxiety during procedures compared with placebo. Intranasal midazolam did not reduce the risk of incomplete procedures, although anxiolysis and sedation were observed. There is moderate-quality evidence suggesting that oral midazolam produces less effective sedation than chloral hydrate for completion of procedures for children undergoing non-invasive diagnostic procedures.
Topics: Administration, Intranasal; Administration, Oral; Adult; Anxiety; Child; Chloral Hydrate; Diagnostic Techniques and Procedures; Diazepam; Humans; Hypnotics and Sedatives; Injections, Intravenous; Midazolam; Randomized Controlled Trials as Topic; Therapeutics
PubMed: 27198122
DOI: 10.1002/14651858.CD009491.pub2 -
The Cochrane Database of Systematic... Mar 2015Electrical cardioversion is an effective procedure for restoring normal sinus rhythm in the hearts of patients with irregular heart rhythms. It is important that the... (Review)
Review
BACKGROUND
Electrical cardioversion is an effective procedure for restoring normal sinus rhythm in the hearts of patients with irregular heart rhythms. It is important that the patient is not fully conscious during the procedure, as it can be painful and distressing. The drug used to make patients unaware of the procedure should rapidly achieve the desired level of sedation, should wear off quickly and should not cause cardiovascular or respiratory side effects.
OBJECTIVES
We aimed to compare the safety, effectiveness and adverse events associated with various anaesthetic or sedative agents used in direct current cardioversion for cardiac arrhythmia in both elective and emergency settings.We sought answers to the following specific questions.• Which drugs deliver the best outcomes for patients undergoing electrical cardioversion?• Does using a particular agent confer advantages or disadvantages?• Is additional analgesic necessary to prevent pain?
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) on 27 March 2014. Our search terms were relevant to the review question and were not limited by outcomes. We also carried out searches of clinical trials registers and forward and backward citation tracking.
SELECTION CRITERIA
We considered all randomized controlled trials and quasi-randomized and cluster-randomized studies with adult participants undergoing electrical cardioversion procedures in the elective or emergency setting.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data, consulting with a third review author for disagreements. We used standard Cochrane methodological procedures, including assessment of risk of bias for all studies.
MAIN RESULTS
We included 23 studies with 1250 participants that compared one drug with one or more other drugs. Of these comparisons, 19 studies compared propofol with another drug. Seven of these compared propofol with etomidate (four of which combined the drugs with remifentanil or fentanyl), five midazolam, six thiopentone and two sevoflurane. Three studies compared etomidate with thiopentone, and three etomidate with midazolam. Two studies compared thiopentone with midazolam, one thiopentone with diazepam and one midazolam with diazepam. Drug doses and the time over which the drugs were given varied between studies. Although all studies were described as randomized, limited information was provided about the methods used for selection and group allocation. A high level of performance bias was observed across studies, as study authors had not attempted to blind the anaesthetist to group allocation. Similarly, study authors had rarely provided sufficient information on whether outcome assessors had been blinded.Included studies presented outcome data for hypotension, apnoea, participant recall, success of cardioversion, minor adverse events of nausea and vomiting, pain at injection site and myoclonus, additional analgesia and participant satisfaction. We did not pool the data from different studies in view of the multiple drug comparisons, differences in definitions and reporting of outcomes, variability of endpoints and high or unclear risk of bias across studies.
AUTHORS' CONCLUSIONS
Few studies reported statistically significant results for our relevant outcomes, and most study authors concluded that both, or all, agents compared in individual studies were adequate for cardioversion procedures. It is our opinion that at present, there is no evidence to suggest that current anaesthetic practice for cardioversion should change.
Topics: Anesthetics; Apnea; Diazepam; Electric Countershock; Etomidate; Fentanyl; Humans; Hypnotics and Sedatives; Hypotension; Mental Recall; Methyl Ethers; Midazolam; Piperidines; Propofol; Randomized Controlled Trials as Topic; Remifentanil; Sevoflurane; Thiopental
PubMed: 25803543
DOI: 10.1002/14651858.CD010824.pub2 -
Cureus Aug 2022Children are particularly terrified of having dental treatment. They are physically resistant, frail, and unwilling to cooperate. This severe distress during the... (Review)
Review
Children are particularly terrified of having dental treatment. They are physically resistant, frail, and unwilling to cooperate. This severe distress during the pre-operative phase could cause the dentist to have issues with behavior control. Additionally, it may make pediatric dental treatments less effective. In order to reduce anxiety and control behavior in children receiving dental care, sedation is a pharmacological management technique that supports the provision of effective and high-quality dental services. The aim is to compare and evaluate the efficacy of sedative agents like dexmedetomidine and midazolam in pediatric dental practice. A thorough review of the literature was conducted using electronic databases like "MEDLINE, PubMed, and CENTRAL (Cochrane Central Register of Controlled Trials), as well as the World Health Organization International Clinical Trials Registry Platform, www.clinicaltrials.gov, conference proceedings abstracts, a bibliography of pertinent references, and manual searches of journals, conferences, and books". There were no restrictions on the language or the date of publication when searching the electronic databases. Randomized controlled trials were included which compared dexmedetomidine and midazolam in children up to 16 years of age subjected to dental treatment. Information on procedures, participants, interventions, outcome measures, and results were independently extracted by three review writers (TS, SL, and RO). Trial authors were contacted for papers that were confusing or lacking information. The risk of bias was evaluated for each study. We adhered to the Cochrane statistical recommendations. Three trials totaling 229 participants were included. All three studies were rated as having a low risk of bias, with none of them having a high or unclear risk. Meta-analysis was done for the available data for the primary outcomes like sedation level and recovery time. We searched for randomized controlled trials up to Jan 31, 2020. Participants are randomly assigned to an intervention or control group in randomized controlled trial research. While patients in the control group often get a placebo therapy or procedure, those in the interventional group receive the treatment being studied. We found three studies eligible to include in the review. One study evaluated 73 individuals who received general anesthesia for dental treatment. There were 72 and 84 individuals in the second and third investigations, respectively. All the participants of the three studies were divided randomly into two groups and were subjected to dexmedetomidine and midazolam as sedative agents. We gave the evidence an "extremely low certainty" rating. Because there are just three short trials with unusual parameters for comparison, the results are questionable. Overall, the results do not allow us to draw any firm conclusions. Three randomized controlled trials included in this systematic review reported data with varying conclusions; hence we recommend more randomized controlled trials to be conducted on this subject matter.
PubMed: 36176880
DOI: 10.7759/cureus.28452