Sedation of children undergoing dental treatment.

BACKGROUND: Children's fear about dental treatment may lead to behaviour management problems for the dentist, which can be a barrier to the successful dental treatment of children. Sedation can be used to relieve anxiety and manage behaviour in children undergoing dental treatment. There is a need to determine from published research which agents, dosages and regimens are effective. This is the second update of the Cochrane Review first published in 2005 and previously updated in 2012. OBJECTIVES: To evaluate the efficacy and relative efficacy of conscious sedation agents and dosages for behaviour management in paediatric dentistry. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 22 February 2018); the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1) in the Cochrane Library (searched 22 February 2018); MEDLINE Ovid (1946 to 22 February 2018); and Embase Ovid (1980 to 22 February 2018). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: Studies were selected if they met the following criteria: randomised controlled trials of conscious sedation comparing two or more drugs/techniques/placebo undertaken by the dentist or one of the dental team in children up to 16 years of age. We excluded cross-over trials. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted, in duplicate, information regarding methods, participants, interventions, outcome measures and results. Where information in trial reports was unclear or incomplete authors of trials were contacted. Trials were assessed for risk of bias. Cochrane statistical guidelines were followed. MAIN RESULTS: We included 50 studies with a total of 3704 participants. Forty studies (81%) were at high risk of bias, nine (18%) were at unclear risk of bias, with just one assessed as at low risk of bias. There were 34 different sedatives used with or without inhalational nitrous oxide. Dosages, mode of administration and time of administration varied widely. Studies were grouped into placebo-controlled, dosage and head-to-head comparisons. Meta-analysis of the available data for the primary outcome (behaviour) was possible for studies investigating oral midazolam versus placebo only. There is moderate-certainty evidence from six small clinically heterogeneous studies at high or unclear risk of bias, that the use of oral midazolam in doses between 0.25 mg/kg to 1 mg/kg is associated with more co-operative behaviour compared to placebo; standardized mean difference (SMD) favoured midazolam (SMD 1.96, 95% confidence interval (CI) 1.59 to 2.33, P < 0.0001, I2 = 90%; 6 studies; 202 participants). It was not possible to draw conclusions regarding the secondary outcomes due to inconsistent or inadequate reporting or both. AUTHORS' CONCLUSIONS: There is some moderate-certainty evidence that oral midazolam is an effective sedative agent for children undergoing dental treatment. There is a need for further well-designed and well-reported clinical trials to evaluate other potential sedation agents. Further recommendations for future research are described and it is suggested that future trials evaluate experimental regimens in comparison with oral midazolam or inhaled nitrous oxide.

Reported side effects of intravenous midazolam sedation when used in paediatric dentistry: a review.

BACKGROUND: Intravenous (IV) midazolam may be of value as an alternative paediatric dental sedation technique, but there is some apprehension concerning its routine use due to a lack of evidence regarding its safety and side effects. AIM: To review all available literature reporting the side effects of IV midazolam in children undergoing dental procedures. DESIGN: Both randomised controlled trials (RCT) and non-randomised studies were reviewed. Reported side effects were categorised as either significant or minor, and the percentage prevalence of significant or minor side effects per episode of treatment was calculated. RESULTS: Five RCTs were included, in which no significant side events were reported; however, minor side effects were recorded (n = 33, 19.5%), with paradoxical reaction being the most common (n = 11, 6.5%). Six non-randomised studies were included, in which no significant side effects were reported; however, minor side effects were reported (n = 118, 16.8%) with paradoxical reaction being the most common (n = 89, 12.7%). CONCLUSIONS: Although no significant side effects were recorded, of the minor side effects reported paradoxical reaction was the most common. Due to inconsistency in side effect reporting, the authors suggest the application of a standardised adverse event reporting tool for future studies of sedation in paediatric dentistry.

An unusual response to intravenous sedation: a case report.

Midazolam is a benzodiazepine commonly used for conscious sedation in dentistry.This paper reports a state of unconsciousness in a 14-year-old girl after administration of midazolam sedation for dental treatment, which was not reversible with flumazenil.The patient remained in an Intensive Care Unit for two days, unresponsive to any stimulus. A range of tests were inconclusive, but the diagnosis of an unusual reaction to midazolam was made. The patient fully recovered and was discharged from hospital after 6 days. A referral to a sleeping disorder clinic was made to investigate the patient's sleeping patterns.This paper highlights the importance of sedation being provided by an appropriately trained team.

Safety of oral midazolam sedation use in paediatric dentistry: a review.

BACKGROUND: Little information is available as to the safety of midazolam when used as an oral sedative. AIM: To evaluate the side effects and other adverse outcomes following use of oral midazolam for behaviour management in paediatric dentistry. DESIGN: A review of published literature relating to the safety and side effects of oral midazolam for use in paediatric dental procedures was conducted. Both randomised controlled trials and non-randomised studies were assessed. Reported side effects were recorded and classified as either significant or minor. The percentage prevalence of significant or minor side effects per episode of treatment was calculated. RESULTS: Sixteen papers of randomised controlled trials met the inclusion criteria. None of the side effects recorded were considered as significant. Minor side effects were reported (n = 68, 14%), with nausea and vomiting being the most frequently recorded (n = 30, 6%). Eleven papers of non-randomised studies were included. No significant side effects were recorded. Minor side effects were recorded (n = 157, 8%), with paradoxical reaction being the most common at 3.8%. CONCLUSION: Significant side effects associated with oral midazolam usage for behaviour management in children and adolescents requiring dental treatment appear to be rare. Minor side effects are more common but determining precise figures is complicated by poor reporting.

Sedation of children undergoing dental treatment.

BACKGROUND: Children's fear about dental treatment may lead to behaviour management problems for the dentist, which can be a barrier to the successful dental treatment of children. Sedation can be used to relieve anxiety and manage behaviour in children undergoing dental treatment. There is a need to determine from published research which agents, dosages and regimens are effective. OBJECTIVES: To evaluate the efficacy and relative efficacy of conscious sedation agents and dosages for behaviour management in paediatric dentistry. SEARCH METHODS: Electronic searches of MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Dissertation Abstracts, SIGLE, the World Wide Web (Google) and the Community of Science Database were conducted for relevant trials and references up to 4th August 2011. Reference lists from relevant articles were scanned and the authors contacted to identify trials and obtain additional information. There were no language restrictions. Trials pre-1966 were not searched. SELECTION CRITERIA: Studies were selected if they met the following criteria: randomised controlled trials of conscious sedation comparing two or more drugs/techniques/placebo undertaken by the dentist or one of the dental team in children up to 16 years of age. Crossover trials were excluded. DATA COLLECTION AND ANALYSIS: Information regarding methods, participants, interventions, outcome measures and results were independently extracted, in duplicate, by two review authors. Where information in trial reports was unclear or incomplete authors of trials were contacted. Trials were assessed for risk of bias. The Cochrane Collaboration statistical guidelines were followed. MAIN RESULTS: Thirty-six studies were included with a total of 2810 participants. Thirty trials (83%) were at high risk of bias and six (17%) were at unclear risk of bias. There were 28 different sedatives used with or without inhalational nitrous oxide. Dosages, mode of administration and time of administration varied widely. Trials were grouped into placebo-controlled, dosage and head-to-head comparisons. Meta-analysis of the available data was possible for studies investigating oral midazolam vs placebo only. There is weak evidence from five small clinically heterogeneous trials at high risk of bias, that the use of oral midazolam in doses between 0.25 mg/kg to 0.75 mg/kg is associated with more co-operative behaviour compared to placebo; standardised mean difference (SMD) favoured midazolam (SMD 2.98, 95% confidence interval (CI) 1.58 to 4.37, P < 0.001, I² = 91%), which translates to an increase of approximately 1.8 points on the six-point Houpt behaviour scale. There is very weak evidence from two trials which could not be pooled that inhalational nitrous oxide is more effective than placebo. AUTHORS' CONCLUSIONS: There is some weak evidence that oral midazolam is an effective sedative agent for children undergoing dental treatment. There is very weak evidence that nitrous oxide inhalation may also be effective. There is a need for further well designed and well reported clinical trials to evaluate other potential sedation agents. Further recommendations for future research are described and it is suggested that future trials evaluate experimental regimens in comparison with oral midazolam or inhaled nitrous oxide.