Title: A clinical trial of comparison of intranasal midazolam and inhalation sedation (N2O/O2) on 3 to 6 year-old children`s behavior under dental treatments
Objectives: Evaluation of the effect of intranasal midazolam and inhalation sedation (N2O/O2) on3 to 6 year-old children`s behavior under dental treatments.
Design: Randomized cross over clinical trial
Setting and conduct: 14 samples were randomly sedated once by the combination of intranasal midazolam with nasal drops of 2% lidocaine hydrochloride without inhalation sedation(A) and once with the combination of inhalation sedation(N2O/O2) with intranasal lidocaine/midazolam (B) in the next session on the same patient . Houpt scoring system was used to evaluate patient`s behavior and depth of the sedation. To compare the redundancy of the items with regards to cross-over design of the study, wilcoxon-Signe Rank test was used.
Participants: 14 patients aged 3 to 6 years old
Variables eligibility criteria: No nasal obstruction; respiratory infection; limitation of neck movement; macroglosia; tonsil hypertension; micrognathia and limitation of mouth opening; ASA=1; at least two sessions needed including pulpotomy or filling of primary upper or lower molar; uncooperative children
Interventions: Administeration of intranasal midazolam and inhalation sedation(N2O/O2)
Main outcome measures: Children`s behaviour under dental treatments
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111930971N1
Registration date:2017-09-27, 1396/07/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-27, 1396/07/05
Registrant information
Name
Nahid Askarizadeh
Name of organization / entity
Dental branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21225645713
Email address
n_asgarizadeh@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2011-12-31, 1390/10/10
Expected recruitment end date
2012-06-27, 1391/04/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial of comparison of intranasal midazolam and inhalation sedation (N2O/O2) on 3 to 6 year-old children`s behavior under dental treatments
Public title
Effect of sedation on children`s behaviour
Purpose
Treatment
Inclusion/Exclusion criteria
No nasal obstruction; respiratory infection; limitation of neck movement; macroglosia; tonsil hypertension; micrognathia and limitation of mouth opening; ASA=1; at least two sessions needed including pulpotomy or filling of primary upper or lower molar; uncooperative children
Age
From 3 years old to 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee , Dental branch, Islamic Azad University, Tehran
Street address
Dental branch, Islamic Azad University, No 4, 10th Neyestan alley, Pasdaran ave, Tehran
City
Tehran
Postal code
Approval date
2011-10-02, 1390/07/10
Ethics committee reference number
692
Health conditions studied
1
Description of health condition studied
behaviour
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
behaviour
Timepoint
The same day
Method of measurement
Houpt scoring system
Secondary outcomes
1
Description
Depth of sedation
Timepoint
Same day
Method of measurement
Houpt scoring system
Intervention groups
1
Description
Administeration of 0.5 mg/kg infusion midazolam via intranasal route in addition to inhalation sedation to the intervention group
Category
Behavior
2
Description
Administeration of 0.5 mg/kg infusion midazolam via intranasal route to the control group
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental branch, Islamic Azad University
Full name of responsible person
Dr Nahid Askarizadeh
Street address
No 4, 10th Neyestan, Pasadaran St, Dental branch,Islamic Azad University, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Dental branch, Islamic Azad University
Full name of responsible person
Dr Nahid Askarizadeh
Street address
No 4, 10th Neyestan, Pasdaran St, Dental branch, Islamic Azad University
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Dental branch, Islamic Azad 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
Dental branch, Islamic Azad University
Full name of responsible person
Dr Nahid Askarizadeh
Position
Associate Professor
Other areas of specialty/work
Street address
No 4, 10th Neyestan, Pasdaran St, Dental branch, Islamic Azad University
City
Tehran
Postal code
Phone
+98 21 8805 3043
Fax
Email
n_asgarizadeh@dentaliau.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Yasaman Rezvani
Position
Faculty member of pediatric ward
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Pediatric ward,Velenjak avenue
City
Tehran
Postal code
Phone
+98 21 2240 3080
Fax
Email
yrezvani5@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)