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Oral Dexmedetomidine vs Midazoam For Premedication

Oral Dexmedetomidine vs Midazoam For Premedication And Emergence Delirium in Children Undergoing Dental Treatment

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03357718
Enrollment
52
Registered
2017-11-30
Start date
2016-11-01
Completion date
2017-06-01
Last updated
2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premedication

Keywords

premedication

Brief summary

The aim of this study was to compare the effect of 2 µg/kg of oral dexmedetomidine (DEX) and 0.5 mg/kg dormicum as premedication among children undergoing dental procedures.

Detailed description

The study involved 52 children between 3-7 years of age, ASA I , who underwent full-mouth dental rehabilitation. The DEX group (n=26) received 2 µg/kg DEX in apple juice, and the control group (n=26) received 0.5 mg/kg midazolam in apple juice. The patients' scores on the Ramsey sedation scale (RSS), parental separation anxiety scale, mask acceptance scale, post-anesthesia emergence delirium scale (PAEDS), and hemodynamic parameters were recorded. The data were analyzed using chi-square test, Fisher's exact test, student t test, and analysis of variance in SPSS.

Interventions

2 µg/kg oral

DRUGMidazolam

0.5 mg/kg

Sponsors

Aydin Adnan Menderes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Intervention model description

Retrospective clinical trial

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
Yes

Inclusion criteria

* The inclusion criteria is age between 3 to 7 years and American Society og Anesthesiology (ASA) grade 1.

Exclusion criteria

* The

Design outcomes

Primary

MeasureTime frameDescription
Ramsey Sedation Scale45 minutes after premedicationSedation level is evaluated due to patient behavior. 1= Patient is anxious and agitated or restless or both, 2=Patient is cooperative, oriented, and tranquil, 3=Patient responds to command only, 4=Patient exhibits brisk response to light glabellar tap, 5=Patient exhibits sluggish response to light glabellar tap, 6=Patient exhibits no response.A Ramsay sedation score '1' was considered as unsatisfactory and ≥ 2 was considered as satisfactory sedation.

Secondary

MeasureTime frameDescription
Parental Separation Anxiety ScalePreoperativeBehavior of the child on seperation from the parents was assessed according to a four-point scale, i.e., the parental seperation anxiety scale (PSAS): 1= Easy seperation, 2=Whimpers but easily reassured, 3=Cries and cannot be easily reassured, but not clinging to parents, 4=Cries and clinging to parents. A PSAS score of 1 and 2 were considered as 'successful parental seperation'.
Mask Acceptance ScoreBefore inductionMask acceptance was evaluated using a four-point scale, i.e., mask acceptance scale (MAS): 1=Excellent (unafraid, cooperative, and accepts mask easily), 2=Good (slight fear of mask , easily reassured), 3=Fair (moderate fear of mask, not calmed with reassurance), 4=Poor (terrified, crying, or combative). The score of 1 and 2 considered as 'satisfactory' mask acceptance.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026