Two oral sedation regimens in pediatric dentistry: a randomized controlled trial

Awj Hammadyeh1, Mohamed Altinawi2 and Faten Rostom3
1 PhD Student, Department of Pediatric Dentistry, Faculty of Dental Medicine, Damascus University, Damascus, (Syria)
2 Professor, Department of Pediatric Dentistry, Faculty of Dental Medicine, Damascus University, Al-Baramkeh, Damascus, (Syria)
E-mail: mohamedaltinawi@gmail.com
3Associate Professor, Department of Anesthesia and Reanimation, Faculty of Medicine, Damascus University, Al-Mazzeh Highway, Damascus, (Syria)
E-mail: fatenrostom@yahoo.fr

Correspondence: Awj Rasheed Hammadyeh
Al-Baramkeh, Damascus, (Syria)
E-mail: aoj.star@hotmail.com
Phone: +963932913839

Received: 20 June 2019,
Reviewed: 30 August, 3 October 2019,
Revised: 3 October, 23 November 2019,
Accepted: 26 November 2019

ABSTRACT

Objectives: Dental procedures are always associated with some degree of anxiety, and children are usually more prone to it. General anesthesia may have to be used in more complex procedures, but many dental procedures can successfully be undertaken with therapeutic sedation. The aim of this trial was to evaluate the effectiveness of oral sedation using dexmedetomidine in comparison with ketamine in the management of uncooperative pediatric patients during dental treatment.
Methodology: A randomized clinical trial was carried out on 40 ASA physical status-I children aged 2-6 y to investigate the effect of using dexmedetomidine and ketamine with atropine for sedation.
The children were equally and randomly divided into two groups: Group K: received oral ketamine 5 mg/kg with atropine 0.01 mg/kg, and Group D: received oral dexmedetomidine 3 µg/kg. Recovery time, vital signs, and side effects were all recorded. Behavior rating was also assessed using the Ohio State University Behavioral Rating Scale (OSUBRS).
Results: The children in Group D were more sedated than in Group K, but the difference was not statistically significant (p = 0.22). The median recovery time was significantly shorter in Group D than in Group K (p = 0.003). No adverse effects, episodes of respiratory or cardiovascular instability were noted in either groups.
Conclusions: Oral dexmedetomidine is equally effective to oral ketamine for sedation in children undergoing outpatient dental procedures, but has relatively a shorter recovery time.
Key words: Behavior; Dexmedetomidine; Ketamine; Sedation
Citation: Hammadyeh A, Altinawi M, Rostom F. Two oral sedation regimens in pediatric dentistry: a randomized controlled trial. Anaesth pain & intensive care 2019;23(4)377-381.
DOI: https://doi.org/10.35975/apic.v23i4.1170

INTRODUCTION

The use of pharmacological regimens like conscious sedation come into help in some pediatric patients who are unable to tolerate dental treatment procedures despite the use of all psychological and behavioral management techniques.1, 2 Various pharmacological agents are used (through different routes) in conscious sedation. ketamine is a sedative drug with an analgesic effect without loss of consciousness when given in the adequate doses.3 However, it may have different side effects,3 including hallucinations,4 nausea, vomiting, and excessive salivation, which may give rise to coughing and laryngospasm.5 Dexmedetomidine is a highly selective alpha-2 agonist which has sedative and analgesic effects.6 7 When dexmedetomidine is given within the appropriate doses provided by the clinical guidelines, it produces dose-dependent analgesia with no consequent respiratory depression.8 The efficacy of oral ketamine has been proved time and again in various clinical studies,5, 9-11 but very few trials have tested the use of dexmedetomidine in oral route.12, 13 Hence, the objectives of this randomized controlled study were to compare the safety and efficacy of oral dexmedetomidine to oral ketamine administered with atropine for uncooperative children undergoing dental procedures.

METHODOLOGY

The study was conducted on 40 normal, ASA-I children of both sexes aged 2–6 y, requiring dental treatment (pulpotomy) under conscious sedation because of their uncooperative behavior (negative and definitely negative behavior on Frankel’s scale).14 All parents gave informed written consent, and ethical and licensing approvals were obtained from the Ethics Committee of Damascus University (No. 2088, date: 7/10/2017).
Each child was subjected to complete clinical evaluation, performed by a pediatric dentist. Fasting instructions were given to the parents preoperatively (6 h: solid foods and non-human milk, 4 h: human milk, and 2 h: water and clear liquids).15 Age, gender, body weight, baseline heart rate, oxygen saturation, and blood pressure were recorded before drug administration, at 10 min interval, and at the end of the procedure.15 Children were randomized into two equal groups (Group K and Group D) according to a computer-generated table of random numbers.
Children in Group K received oral ketamine hydrochloride 5 mg/kg with atropine 0.01 mg/kg.
In Group D, children received dexmedetomidine 3 µg /kg orally. After preparing the drug appropriate to child’s body weight, the drug was mixed with a cherry juice, to mask the taste and make it more palatable, and administered. When the desired level of sedation was achieved, the dental procedure was performed by an experienced pediatric dentist.
The behavior of each child was rated during treatment according to Ohio State University Behavioral Rating Scale (OSUBRS) (Table 1).

Table 1: Ohio State University Behavior Rating Score (OSUBRS)
Score Behavior
1 Quiet behavior, no movement
2 Crying, no struggling
3 Struggling movement without crying
4 Struggling movement with crying
Sedation onset, and recovery times were recorded, and side effects were observed. The children were discharged when fully conscious, and all vital signs were within normal range.
Statistical analysis:
Data were analyzed using Mann–Whitney, U-test, and Student’s t-test. p < 0.05 was the criterion for statistical significance. The statistical package used for all data was SPSS® version 21 (IBM® SPSS, USA).

RESULTS

A total of 40 healthy children aged (2–6 years)\ were included in the study. They were homogenous with respect to age, weight, gender, preoperative behavior, and the type of procedure (Table 2).
The behavior scoring was based on OSUBRS. In Group K, the score was 1 (quiet behavior, no movement) in 4 (20%) children, 2 (crying, no struggling) in 9 (45%), 4 (Struggling movement without crying) in 4 (20%), and 4 (Struggling movement with crying) in 3 (15%) children. On the other hand, in Group D, 7 (35%) children had a score of 1, 7 (35%) had a score of 2, while it was 3 in 3 (15%), and 4 in 3 (15%) children.

Table 2: Demographic characteristics in two groups
Parameter Group K
(n=20)		 Group D
(n=20)
Age in Years (Mean ± SD) 3.9 ± 0.5 4.1 ± 1.1
Weight in Kg (Mean ± SD) 13.1 ± 5.1 14.3 ± 6.1
Male : Female 9:11 8:12
Table 3 shows the mean OSUBRS scores in both groups. Children who received dexmedetomidine had achieved better behavior than Group K. However, there was no significant difference between the two groups in mean OSUBRS scores as noted by the external assessor during treatment, (p = 0.22, Mann–Whitney).
The median recovery time with dexmedetomidine was shorter than that for ketamine, 19.36 ± 1.9 min vs. 25.01 ± 1.8 min respectively. there were statistically significant differences according to Student’s t-test, the p-value for this comparison is 0.003.
The oxygen saturation was > 97% in all children. No adverse effects, no episodes of respiratory or cardiovascular instability, and oxygen desaturation were recorded in both groups whether during the procedures or even throughout the recovery.

Table 3: Comparison of behavior scores during the procedure and the sedation / recovery parameters [Data given as Mean ± SD]
Parameter Group K
(n=20)		 Group D
(n=20)		 p-value
OSUBRS scores 2.3 ± 2.1 2.2 ± 1.6 p = 0.22
Recovery time in min 25.01 ± 1.8 19.36 ± 1.9 p = 0.003
DISCUSSION

The greatest challenge faced by pediatric dentists in daily practice is an uncooperative patient. It can be a serious hindrance to provide the required dental care.17,18 Most of the children can be managed effectively using the techniques involving basic behavior guidance and coaxing, but still a significant proportion of children require advanced behavior guidance techniques including conscious sedation with therapeutic agents.15 Dexmedetomidine is a sedative with analgesic properties, and has been proven to produce a desirable and safe sedation for children in daycare surgical settings. It exhibits minimal cardiovascular or respiratory effects.7,19,20  Despite these excellent attributes, data regarding the use of oral dexmedetomidine for outpatient dental treatment in pediatric dentistry are still limited.21,22 This randomized clinical trial demonstrates that oral dexmedetomidine 3 mg/kg could provide effective and safe sedation for children undergoing outpatient dental procedures, comparable to that provided by ketamine.
Children in the dexmedetomidine group showed a quieter attitude at all times during the treatment procedure, when compared to those who received ketamine. Seven out of 20 children in the dexmedetomidine group scored 1± quiet behavior (no movement), compared to four in the ketamine group. The difference in mean OSUBRS scores was not significant as can be seen in Table 3. The lack of significance may be attributed to the small sample size.
There is no study in the dental field comparing the use of oral dexmedetomidine to ketamine with atropine. This is the first comparative study of its kind, especially with the mentioned dosage. The study resembling our study compared dexmedetomidine to ketamine alone, conducted by Singh et al., who reported that the novel sedative dexmedetomidine (3/4/5 µg/kg) provides dose-dependent effective analgo-sedation, comparable to ketamine (8 mg/kg), with less adverse effects. This comes in complete agreement to the results reached by the present study.23 Regarding the results of our study, the use of dexmedetomidine led to an earlier awakening and discharge than ketamine. Children who received dexmedetomidine were effectively sedated yet were easily arousable; a feature not observed with children of the ketamine group. It may be due to dexmedetomidine-induced sedation is characterized by a quick recovery, actually mimicking some aspects of natural sleep.6,24 Similar results were found in a study carried out by Singh et al., who noted that children in the dexmedetomidine group had earlier recovery than those in the ketamine group.23 In this study, no patient experienced serious complications in either of the two groups, nor any patient required termination of the procedure or any pharmacologic intervention. This finding confirms the ​​safety of dexmedetomidine,25,26 and this is consistent with several earlier studies that utilized dexmedetomidine.23,27,28 It also enhances the benefit of the prophylactic co-administration of atropine (anticholinergic) as an adjunct in sedation with ketamine. it is in accordance with the findings of other studies which reported that it reduces the hypersalivation, excessive secretions of the respiratory tract, and nausea and vomiting,29, 30 which are the most common complications with ketamine.5,31
CONCLUSION

Within the limitations of this study it can be concluded that both dexmedetomidine and ketamine produce good and effective oral sedation, and they were satisfactory in managing children during outpatient dental procedures, although the oral dexmedetomidine led to earlier recovery than ketamine, and the addition of atropine as an adjunct for oral ketamine sedation in children helps in preventing complications and side effects.
Acknowledgment: The authors are grateful for the financial support provided by the Faculty of Dentistry, and the Department of Anesthesia and Reanimation, Faculty of Medicine, Damascus University, Damascus (Syria).
Conflict of interest: None declared by the authors.
Authors’ contribution:
AH: Conduction of the study work, data collection, statistical analysis, manuscript editing.
MA: Concept, conduction of the study work, manuscript editing.
FR: Conduction of the study work, data collection manuscript editing

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