الفهرس 
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Abstract
Dental fear and anxiety are a widely recognized problem affecting young children,
resulting in avoidance of dental care, and are considered the global barrier in Pediatric
Dentistry. Moderate sedation is considered an option for treating children in whom basic
behavior management techniques fail. The goals of procedural sedation and analgesia are to
enhance the child‟s physical comfort and safety to allow for the completion of the procedure
successfully, to control anxiety, and as well as to modify future behavior toward dental
treatment. These goals can best be achieved by selecting the lowest dose of drug with the
highest therapeutic index for the procedure.
Nebulized administration of sedative drugs has been introduced since 2008 as an
intranasal (IN) route of administration. It is an acceptable, effective, rapid and safe route.
Midazolam (MID) is the classical pediatric procedural sedative drugs. It is an effective
anxiolytic, muscle relaxant, and amnesic agent. Lately, Dexmedetomidine (DEX) has been
introduced clinically for procedural sedation. DEX has anxiolytic, sympatholytic, and
analgesic effects. An important feature of Dexmedetomidine-based sedation is to maintain
spontaneous ventilation and preserve upper airway tone. This makes DEX an interesting safe
alternative pediatric procedural sedative drug.
In Dentistry, to obtain high-quality sedation, analgesia and amnesia, the addition of
MID to DEX may be an appropriate combination. The aim of the study is to evaluate and
compare the efficiency and safety of nebulized Midazolam, Dexmedetomidine and their
combination as procedural, moderate sedative drugs in preschoolers undergoing dental
treatment.
The study was a three-armed, triple-blind randomized clinical trial; parallel design.
The study followed the CONSORT guidelines. It was conducted on preschoolers (aged 4-6
years) attending the outpatient clinic of the Pediatric Dentistry and Dental Public Health
Department, Faculty of Dentistry, Alexandria University. A total of seventy-two healthy
(ASA I or II physical status), uncooperative (Frankl scale score 1 or 2) preschoolers, requiring
dental intervention under local anesthesia for not more than 30 minutes were enrolled in the
study. After parental written consent, the participants were randomly allocated into 3 groups.
Children of group I received nebulized solution of 0.5 mg/kg Midazolam, group II received
nebulized solution of 5μg/kg Dexmedetomidine, and group III received a nebulized solution
of 0.3 mg/kg Midazolam and 3μg/kg Dexmedetomidine respectively.
On the day of sedation, the proper designated drug dosage was prepared. During the
sedative medication was nebulized, nebulizer mask acceptance was recorded according to
Zanaty & Metainy. Once satisfactory sedation level was reached (according to Wilton et al.
sedation scale) the dental treatment was started. Each session was filmed for analysis: ease of
treatment completion, child sedation level: using Observer‟s Assessment of
Alertness/Sedation Scale, and analgesic effect using „Face, Legs, Activity, Cry,
Consolability‟ scale at time of local anesthesia administration.
All vital signs including (SBP, DBP, HR, and SaO2) were monitored and recorded at
at baseline, after nebulizing first drug dosage, after nebulizing second drug dosage, before
discharge. The effect of each drug was assessed according to their safety based on vital signs,
time of onset, and duration of sedation. The most common procedural and postoperative side
effects, anterograde amnesic effect were assessed as well. One week later, a follow-up session
took place to reassess the child behavior toward dental visit using Frankl scale.
It was found that there was no difference regarding acceptance of nebulizer face mask
for all children and no adverse effect had been reported. The major drawback for using the
nebulizer was the prolonged time of administration, which might hinder the effective dosage
in case of short acting sedative drugs. The sedative effect of nebulized drug might have been
affected by the prolonged administration, which was assessed by Observer‟s Assessment of
Alertness/Sedation (OAA/S). In the present study, the components of OAA/S scale showed
that children who were nebulized with DEX were consistent in the range of moderate
sedation, whereas children who were nebulized with MID showed heterogenic behaviors.
Although the responsiveness and speech of sedated children with nebulized MID were in a
state of moderate sedation, their facial expressions and eye ptosis showed they were mild
sedation state. Conversely, children who were sedated with DEX/MID showed deep sedation
state during responsiveness and speech, but their facial expression and eye ptosis showed mild
state of sedation. The addition of MID to DEX appeared to decrease the easy arousability.
Children who were nebulized with DEX had a significantly delayed onset of sedation
than those sedated by either nebulized MID or DEX/MID. As for the duration of sedation,
there were significant differences between the three groups, where MID had the shortest
duration and DEX/MID had the longest duration of action. The combination of DEX/MID
had the most rapid onset and the longest duration of action among either MID or DEX groups.
The combination between the two sedative drugs benefits from synergistic effect of both; as
MID has a rapid onset of action while DEX has a more prolonged effect.
Although DEX is known for the beneficial analgesic effect, there was no significant
difference between DEX and either MID or DEX/MID. Treatment was successfully
completed for all children with a statistical difference in ease of treatment between the DEX
and MID groups. It was significantly easier to treat children who were sedated with nebulized
DEX than children sedated with either MID or DEX/MID. The sympatholytic effect of DEX
creates a more stable profile during stressful events.
Children who were sedated with nebulized DEX/MID and MID showed signs of
agitation during operative procedure than children who were sedated with nebulized DEX. In
case of DEX/MID sedation in the current study, 66.7% of children were agitated during
operative procedure. Vomiting was significantly apparent among children who were sedated
with either nebulized MID or DEX/MID, but none of the patients in both groups had
vomiting. However, nausea was comparable among children of all groups. Shivering was
significantly higher in children who were nebulized with DEX than other children; it could be
related to vasoconstriction for peripheral vasculature due to sympatholytic effect of DEX.
The safety of sedative drugs was assessed in terms of vital signs including (SBP, DBP,
HR, and SaO2).In present study mild hemodynamic effects were reported but these effects
were clinically insignificant, and no intervention was required. Sedation with DEX was
associated with bradycardia, while sedation with MID and DEX/MID was associated with
tachycardia. Hypotension was more common among children sedated with MID than DEX
regimens (DEX, DEX/MID). Dexmedetomidine can decrease sympathetic outflow, leading to
hypotension and decreased heart rate. The mean values of SBP, DBP and HR among children
sedated with DEX/MID had the lowest values than other children. This is due to synergistic
effect of both DEX and MID. In present study MID, DEX, and their combination DEX/MID
have similar results regarding the oxygen saturation during the whole sessions. The average
oxygen levels remained stable for all children.
Amnesia during dental treatment is highly beneficial in pediatric dental patients.
Although MID is characterized by amnesic effect, in the current study no significant effect of
MID over DEX regarding anterograde amnesia was found. MID caused anterograde amnesia
in a dose-responsive manner, and it was affected by the patient characteristics. The change in
behaviour of children toward dental treatment was obvious between examination session and
follow up session. More than half of children of all groups started to show positive and
definitely positive behaviour toward dental sessions. Children who were sedated with
nebulized DEX showed better change in behaviour followed by those who were nebulized
with DEX/MID. The change in behaviour is thus assumed to be more related to the smooth
and ease of sedation session rather than the amnesic effect.
It was concluded that nebulization of sedative drugs is an acceptable route of
administration for preschool children, regardless of its prolonged time of administration. On
overall assessment, 5 μg/kg DEX appeared to be clinically reliable and safe in terms of
sedation level, ease of treatment completion, and analgesia. Dexmedetomidine seemed to be a
better choice for its respiratory stability. It could be concluded that DEX works better than
either MID or their combination for procedural sedation and analgesia for preschool children
undergoing dental treatment.