|Year : 2019 | Volume
| Issue : 4 | Page : 385-392
Dexmedetomidine versus midazolam for conscious sedation in children undergoing dental procedures
Salwa H Waly
Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Zagazig University, Zagazig, Egypt
|Date of Submission||07-Nov-2018|
|Date of Acceptance||30-Apr-2019|
|Date of Web Publication||06-Jan-2020|
MD Salwa H Waly
Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Zagazig University, 17 El Khashab Street, Behind El Mabarra Hospital, Zagazig 44511
Source of Support: None, Conflict of Interest: None
Background Pediatric dental sedation aims to have a cooperative child who is required to keep his mouth open during the procedure. Achieving the proper level of sedation might subject the child to circulatory and ventilatory troubles, which draws the attention toward performing researches for the proper sedative to be used in such circumstances.
Aim of the work This study compares the effect of two sedatives (dexmedetomidine vs. midazolam) in children undergoing dental procedures.
Patients and methods A total of 60 ASA I children aged 6–10 years who were scheduled for lower jaw dental procedure were enrolled in the current study. Children were randomized into two equal groups. In group D (dexmedetomidine group, n=30), 2-µg/kg dexmedetomidine was administered intravenously over 5 min as induction dose, followed by continuous infusion of 0.4 µg/kg/h as a maintenance. In group M (midazolam group, n=30), 0.05 mg/kg midazolam was administered intravenously followed by maintenance dose of 0.06–0.12 mg/kg/h titrated according to patient response. Local infiltration anesthesia was given by the dentist as 0.5 mg/kg mepivacaine 2%.
Results In this study, mean arterial blood pressure, heart rate, respiratory rate, and oxygen saturation showed no significant differences between both groups. The time of onset of sedation was comparable between both groups (4.7±1.1 vs. 4.1±1.8 min in group D and group M, respectively). However, recovery time was highly significantly shorter in group D compared with group M (14.3±1.1 vs. 20.2±9.8 min, respectively). The duration of the procedures (24.7±3.1 vs. 22.2±7.5 min in group D and group M, respectively) and discharge times (14.1±2.2 vs. 13.5±5.9 min in group D and group M, respectively) were comparable between both groups. Number of patients requiring supplemental analgesia was significantly lower in group D compared with group M (6 vs. 16, respectively). Dentist satisfaction was equivalent in both groups of the study.
Conclusion Dexmedetomidine and midazolam are safe and effective for consciously sedating pediatric patients undergoing dental procedures. Dexmedetomidine shows faster recovery and better postoperative analgesia compared with midazolam.
Keywords: conscious sedation, dexmedetomidine, midazolam, pediatric dentistry
|How to cite this article:|
Waly SH. Dexmedetomidine versus midazolam for conscious sedation in children undergoing dental procedures. Res Opin Anesth Intensive Care 2019;6:385-92
|How to cite this URL:|
Waly SH. Dexmedetomidine versus midazolam for conscious sedation in children undergoing dental procedures. Res Opin Anesth Intensive Care [serial online] 2019 [cited 2020 Feb 26];6:385-92. Available from: http://www.roaic.eg.net/text.asp?2019/6/4/385/275145
| Introduction|| |
Consciousness is a continuum in which levels can be recognized. The American Society of Anesthesiologists has classified the levels of sedation into three levels as shown in [Table 1] . Conscious sedation is defined as drug-induced depression of consciousness, similar to moderate sedation, except that verbal contact is always maintained with the patient . Thereby, with such level of sedation, the patient is always responsive to the spoken word. This definition is most commonly used in dentistry .
Uncooperative or unmanageable child in pediatric dentistry is a major problem as it may force the dentist into unwanted consequences such as delay or termination of treatment before completion .
Drugs and techniques used for conscious sedation should have a wide safety margin to guard against losing the patient cooperation . However, the incidence of airway obstruction and inadequate spontaneous ventilation depends mainly on the skill and judgment of the attending anesthesiologist . Thereby, sedation should only be performed in situations where there are facilities, equipment, and personnel to prevent or manage deep sedation .
Midazolam (a short acting benzodiazepine) has gained a wide reputation as a sedative to be used for conscious sedation owing to its amnestic and anxiolytic properties. Moreover, it has limited cardiovascular effects, with quick recovery and no postoperative adverse reactions such as nausea and vomiting .
Dexmedetomidine (a centrally acting α2-agonist) has both sedative and analgesic properties . It does not cause respiratory depression; however, hemodynamics must to be closely monitored, as it produces dose-dependent decrease in blood pressure and heart rate resulting from its sympatholytic effects . It has minor effects on cognitive function, thus giving the chance for easy communication and cooperation with the patient .
The aim of the current study is to compare both efficacy and safety of dexmedetomidine versus midazolam for conscious sedation in children undergoing dental procedures.
The primary outcome in the current study is to compare the time of onset of sedation between the dexmedetomidine and midazolam.
Secondary outcome is to compare the recovery time, discharge time, hemodynamic stability, complications, and postoperative analgesia between the two drugs of the study.
| Patients and methods|| |
This is a randomized prospective study that was conducted in Zagazig University Hospitals during the period from April 2015 to February 2016 after obtaining Institutional Research Board approval as well as parental or guardians’ written informed consent. The study included 60 the American Society of Anesthesiologists I physical status children aged 6–10 years who were scheduled for lower jaw dental procedure (teeth extraction, pulpotomy with composite resins filling, or cavity preparation with composite resins filling). Children included in this study were referred from outpatient clinic of dentistry for being anxious and uncooperative which increased the difficulty during performing the dental procedure with local anesthesia only. All the patients had no previous experience with dental procedures. Exclusion criteria included congenital anomalies, mental disorders, delayed milestones, major organ disease, or history of drug allergy.
Patients were kept fasting for 8 h with allowing clear fluids up to 2 h before sedation. All children were weighed in kg and completely examined on the day before the maneuver. All preparations to ensure patient safety were performed, including the procedure was performed in operation room to ensure the availability of proper monitoring, measures for securing and maintaining a patent airway, artificial ventilation, general anesthesia, and cardiopulmonary resuscitation if needed. A 22G cannula (Harsoria Healthcare, Harynana, India) was inserted as an intravenous line before starting sedation with previous administration of EMLA cream (2 h earlier) EMLA 5% cream (active ingredients:2.5% Lidocaine, 2.5% Prilocaine, AstraZeneca. Egypt), and then atropine sulfate 0.01 mg/kg was given intravenously.
For the aim of psychological preparation of the child and gaining his trust, some explanation about what the child will experience and what they should do to cooperate was done by the dentist for all children in the study. Either one or both of the parents helped reassuring the child during the procedure. Presedation behavior was assessed by a team member blinded to the study protocol according to a four-point scale  (1=calm, cooperative; 2=anxious but reassurable; 3=anxious and not reassurable; 4=crying or resisting). Scores 1 and 2 were considered as undistressed, whereas scores 3 and 4 were considered as distressed.
Children in the present study were then randomized into two equal groups (group D and group M) using closed envelope technique. In group D (dexmedetomidine group, n=30), 2 µg/kg dexmedetomidine was administered intravenously over 5 min as induction dose, followed by continuous infusion of 0.4 µg/kg/h dexmedetomidine as a maintenance dose using a syringe pump. If at any time the patient needed an incremental dose of sedation (e.g. unwanted movement was elicited), 0.4 µg/kg dexmedetomidine was administered to restore the level of sedation. In group M (midazolam group, n=30), 0.05 mg/kg midazolam was administered intravenously as induction dose followed by maintenance dose of 0.06–0.12 mg/kg/h titrated until the targeted level of sedation is reached and maintained using a syringe pump, with a total dose of up to 0.4 mg/kg to a maximum of 10 mg to avoid the risk of hypoventilation. We aimed to reach a Ramsay Sedation Scale  (RSS) of at least 5 with either of the drugs used in the study ([Table 2]).
Just after injection of the sedative drug, O2 supplementation at 4 l/min using nasal cannula was applied. Patients were monitored using noninvasive blood pressure monitoring, ECG, and pulse oximetry. Restraining belt was also applied to guard against unwanted movement during the procedure.
For both groups, study drugs were given by an anesthetist that is blinded to the experimental protocol. Following sedation, the dentist was asked to wait until the child reaches the targeted level of sedation before local infiltration anesthesia was given by the dentist (using Mepecaine-L 1.8 ml carpule containing mepivacaine hydrochloride 2% with levonordefrin 1 : 20 000. Alexandria Co for Pharmaceuticals. Alexandria, Egypt). The dose of local anesthetic injected was 0.5 mg/kg mepivacaine 2%. Then the dental procedure could be performed 1 min later. During the procedure, a supplementary dose of 0.25 mg/kg of mepivacaine was given if needed.
After the end of dental procedure, drug infusion was stopped, and the decision to discharge patients was taken Steward Recovery Score  of 6 was reached ([Table 3]).
Data were collected by a physician who is blinded to experimental protocol using a sheet titled by the label code of study drugs present on the used syringes.
Data collected included mean arterial blood pressure (MAP), heart rate (HR), respiratory rate (RR), and oxygen saturation (SPO2). Data were recorded before starting sedation (baseline) and then every 5 min until time of discharge from operation room. The following definitions were encountered: hypotension (MAP<30% of basal), bradycardia (HR<60 beats/min), bradypnea (RR<12 breath/min), and hypoxia (SPO2<92% on nasal cannula 4 l/min).
The time of onset of sedation was considered as the time from the end of the loading dose to the achievement of RSS of 5 or more.
The duration of procedure was considered as the time from achieving the required RSS till the end of the procedure when the drug infusion was stopped.
The recovery time was considered as the time from stopping drug infusion till regaining a level of consciousness of 2 following the RSS.
Time of discharge was considered as the time from stopping drug infusion till the discharge of the child at a Steward Recovery Score of 6.
Unwanted movements or any other complications (airway, ventilation, hemodynamic, or allergic problems) were recorded if occurred. In the recovery room, patients were monitored by a blinded physician who recorded the time at which child achieved Stewart Recovery Score of 6 and observed the needs for pain relief according to FLACC scale  (The Face, Legs, Activity, Cry, Consolability scale) as shown in [Table 4]. Paracetamol hydrochloride 15 mg intravenously was given as supplemental analgesia if FLACC scale was greater than 4. The number of patients requiring postoperative supplemental analgesia was recorded.
All the procedures in the current study were performed by the same dentist who was blinded to the study groups. Dentist satisfaction was assessed using a scale of 1–3 (3: good, 2: fair, and 1: poor) in both groups of the study.
Sample size detection and statistical analysis
The power of this clinical trial was prospectively calculated using G*POWER program, version 18.104.22.168, (Heinrich Heine, Universitat Dusseldorf, Germany). To calculate sample size, the time of onset of sedation was used as the primary outcome. Thirty patients were needed in each group to achieve an α error level of 0.05, with 80% power and 95% confidence limit. Allowing a 5% drop out rate, the final sample size needed was 30 patients in each group to detect clinically significant difference of greater than 20%.
The software SPSS, version 15.0 (SPSS Inc., Chicago, Illinois, USA) for windows was used for statistical analysis. Nominal data and qualitative data were presented as number or percent of total. Parametric data were presented as mean± SD. Continuous data (HR, MAP, etc.) were analyzed using repeated measure analysis of variance. A Tukey post-hoc test was performed if statistical significance was reached to identify level of significance. Age, weight, and the different times recorded in the study were analyzed using independent t-test, whereas sex, type of procedure, incidence of adverse effects, and need for postoperative analgesic were analyzed using χ2 or Fischer’s exact test as appropriate. A P value less than 0.05 was considered as statistically significant.
| Results|| |
The results obtained in the present study showed that patients’ characteristics and types of dental procedure were comparable between both groups ([Table 5]).
|Table 5 Patients’ characteristics and types of dental procedure in both groups|
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MAP, HR, SO2, and RRs showed no significant differences between both groups and during all recorded times of the study, as shown in [Figure 1],[Figure 2],[Figure 3],[Figure 4], respectively.
|Figure 1 Changes in mean arterial blood pressure (MAP/mmHg) in both groups.|
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The time of onset of sedation (RSS≥5) was comparable between both groups (4.7±1.1 vs. 4.1±1.8 min in group D and group M, respectively). However, recovery time (RSS=2) was highly significantly shorter in group D compared with group M (14.3±1.1 vs. 20.2±9.8 min, respectively). Regarding the duration of the procedures, which were 24.7±3.1 min in group D versus 22.2±7.5 min in group M, and discharge times were 14.1±2.2 min in group D versus 13.5±5.9 min in group M, results were comparable between both groups. Number of patients requiring supplemental analgesia was significantly lower in group D compared with group M (6 vs. 16, respectively), as shown in [Table 6].
|Table 6 Time of onset of sedation, length of the procedure, recovery time, discharge time, and the number of patients requiring supplemental analgesia in both groups of the study|
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Dentist satisfaction was equivalent in both groups of the study. The dentist opinion that both are good techniques to be performed during dental procedures in uncooperative children ([Table 7]).
None of the patients needed an incremental dose of sedation or local anesthetic during the procedure. No patient in both groups has experienced airway, ventilation, hemodynamic, or allergic problems. Except for lack of mouth sensation, no further complaints from the children were recorded.
| Discussion|| |
The results obtained in the current study showed that both dexmedetomidine (given as 2 µg/kg for induction dose, followed by continuous infusion of 0.4 µg/kg/h as a maintenance dose) and midazolam (where 0.05 mg/kg midazolam was administered as induction dose followed by maintenance of 0.06–0.12 mg/kg/h) are safe and effective for achieving conscious sedation in pediatrics undergoing dental procedures. Moreover, children in dexmedetomidine group showed more rapid recovery and less number of patients requiring postoperative supplemental analgesia when compared with midazolam group.
Regarding the safety precautions considered during performing pediatric conscious sedation, it was a surprise to find out that some countries allow ketamine and even other anesthetics to be used by nonanesthetists. The UK National Institute for Clinical Excellence guideline (number 112)  recommended the following:
- A healthcare professional using specialist sedation techniques needs to be trained to administer sedation drugs safely, to monitor the effects of the drug and to use equipment to maintain a patent airway and adequate respiration.
- A health care professional trained in delivering anesthetic agents is available to administer sevoflurane, propofol, or opioids combined with ketamine.
Other guidelines by American Academy of Pediatrics and American Academy of Pediatric Dentistry  recommended that during providing moderate sedation to children, the dentist should be aware and qualified to manage any predicted complications and should never provide this type of sedation unless accompanied by another qualified physician who is responsible for monitoring the patient and qualified to manage any predicted complications.
Finally, the Scottish Intercollegiate Guidelines Network guidelines on safe moderate sedation techniques  recommended that intravenous sedation for pediatric dentistry should be held by a consultant-lead-team who has a special expertise in pediatric sedation and in a specialized center or hospital which meets the standards for general anesthesia. In the current study, SIGN guidelines were followed to ensure patient safety.
Midazolam is the most common agent to be used for sedation owing to its rapid onset and short duration of action . Kalibatiene et al.  and Day et al.  studied the efficacy and safety of midazolam and recommended it in managing young children with behavioral problems before dental surgery, and they recommended that efforts should be made to overcome its bitter taste when used orally. Studies concerned with the use of intravenous midazolam for sedating children at dental outpatients are few, for fear of deep sedation, the risks of airway obstruction, hypoventilation and hypoxia . Thereby, the current study was conducted in operation room to ensure patient safety.
Dexmedetomidine acts by binding to α2 receptors presynaptically and postsynaptically in the locus ceruleus and in the spinal cord resulting in decrease norepinephrine release and inhibiting of sympathetic activity which may lead to bradycardia and hypotension . However, in the present study dexmedetomidine showed stable hemodynamics which comes in consistent with the results obtained in a study by Al Taher et al. . A possible explanation might be that children in the present study and in a study by Al Taher et al.  were given intravenously 0.01 mg/kg atropine sulfate as a premedication which may have protected the children against the sympatholytic effect of dexmedetomidine. Another explanation might be that appropriate dose and appropriate transfusion velocity of dexmedetomidine provides favorable cardiovascular stability .
It is difficult to find a lot of studies dealing with the use of dexmedetomidine in nonintubated children as it was approved by Food and Drug Administration agency as a sedative for nonintubated patients only on late 2008 . However, the safety with dexmedetomidine has been studied by Tug et al.  who compared higher doses of dexmedetomidine (3 vs. 4 µg/kg) for sedating children undergoing MRI and found that the higher (4 µg/kg) dose to be more successful without adverse effects. Moreover, the study by Devasya and Sarpangala  revealed that dexmedetomidine is a good choice for sedation in dentistry.
In respect to the faster recovery time in dexmedetomidine than midazolam group, these results agreed with the results obtained by Koroglu et al.  and Al Taher et al.  However, Pandharipande et al.  demonstrated longer recovery times with dexmedetomidine compared with lorazepam. This might be attributed to the lengthy duration of use and the different group of patients, as they studied the sedative effect of these drugs on acute brain dysfunction in mechanically ventilated patients.
The pain during dental procedure is so severe and therefore the use of local anesthesia is essential. Once the local anesthetic has been properly injected, requirements for sedation may be much less . This statement comes in agreement with the results obtained in the present study where none of the children needed incremental doses for sedation intraoperatively. However, in the study by Mikhael et al. , some of the children needed incremental doses of sedation which might be explained by different methodology as they gave one shot of ketamine 0.2–0.3 mg/kg, alfentanil 5–20 µg/kg, and midazolam 0.1–0.2 mg/kg with no maintenance dose besides that some of the procedures exceeded 30 min duration.
In the present study, the number of patients in dexmedetomidine group who needed postoperative analgesic supplementation was less than that in midazolam group which might be attributed to the analgesic effect of dexmedetomidine ,. This finding comes in accordance with the results obtained by many studies ,, which concluded that patients who receive dexmedetomidine for sedation show lower pain scores and less requirements for postoperative analgesia.
| Conclusion|| |
Both dexmedetomidine (given as 2 µg/kg for induction dose, followed by continuous infusion of 0.4 µg/kg/h as a maintenance dose) and midazolam (given as 0.05 mg/kg midazolam as induction dose followed by maintenance of 0.06–0.12 mg/kg/h) might be considered safe and effective and can provide adequate sedation enough to control anxiety and unwanted movements in children undergoing dental procedures. Moreover, dexmedetomidine shows faster recovery and better postoperative analgesia than midazolam.
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Conflicts of interest
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]