Providing a safe and efficient dental treatment for a young patient is a challenge for the dentist and the child. The purpose of this study was to investigate the effectiveness, safety and acceptability of buccal Midazolam in dental pediatric patients and to compare it with oral Midazolam.
Methods: Eighteen uncooperative healthy children aged 2.5-6 years were randomized to each of buccal midazolam (0.3mg/kg) or oral midazolam (0.5mg/kg) at the first visit, the alternative has been used at the second visit in a cross-over manner. The study took place at pediatric dentistry clinic of Shahed University, Tehran, Iran from November 2011 to June 2012. The patients` vital signs and behavioral scores were recorded. The patient, the operator and the observer were blinded to the applied medication. Post operatively, patients` and parents` satisfaction were assessed by Visual Analogue Score and a questionnaire respectively. The P-Value was set at 0.05 for significance level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013020312350N1
Registration date:2013-05-11, 1392/02/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-11, 1392/02/21
Registrant information
Name
Rahil Ahmadi
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 9210
Email address
ra.ahmadi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral and buccal midazolam for pediatric dental sedation: A randomized, cross-over, clinical trial for efficacy, acceptance and safety
Public title
Comparison of oral and buccal midazolam for pediatric dental sedation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: those who needed bilateral and identical restorative and pulp treatment requiring 2 or more dental visits and were unable to tolerate the dental procedure with behavior management techniques. Those with contraindication to Midazolam, upper respiratory tract infection, tonsilar hypertrophy were excluded.
Group 1 received 0.5 mg/kg oral Midazolam syrup (Amsed, 2.5 mg/ml, Dales Pharmaceutical, England) 30 -45 minutes before treatment
Category
Treatment - Drugs
2
Description
Group 2 was given 0.3 mg/kg buccal Midazolam (Epistatus, 10mg/ml, Special Product Ltd, England), 15-30 minutes prior dental procedure. The other regimen was used at the second appointment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahed University
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental school- Shahed University
Full name of responsible person
Dr Abbasi
Street address
No. 73, Italia st.
City
Tehran
Grant name
پژوهانه
Grant code / Reference number
717
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental school- Shahed University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Sara Tavassoli
Position
Assisstant professor
Other areas of specialty/work
Street address
No. 73, Italia st.
City
Tehran
Postal code
Phone
+98 21 8895 9210
Fax
Email
tavasolisara@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Sara Tavassoli
Position
Assisstant professor
Other areas of specialty/work
Street address
No. 73, Italia st.
City
Tehran
Postal code
Phone
+98 21 8895 9210
Fax
Email
tavasolisara@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Rahil Ahmadi
Position
Pediatriic dentist
Other areas of specialty/work
Street address
No.71, Italia st.
City
Tehran
Postal code
1417755351
Phone
+98 21 8895 6227
Fax
+98 21 8896 7618
Email
rahilsh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)