A comparison of the sedative effectiveness of oral combinations of midazolam/ketamine and midazolam /hydroxyzine in uncooperative pediatric dental patients
PURPOSE: This study was undertaken to compare the effectiveness of oral combinations of midazolam/ketamine and midazolam /hydroxyzine for sedation in pediatric dental patients. METHODS: this study was a clinical trial of 25 uncooperative children, aged 37 to 56 months in need of at least 2 restorative visits. The subjects were assigned randomly to receive either the combination of midazolam 0.5 mg/kg and ketamine 5mg/kg or midazolam 0.5 mg/kg and hydroxyzine 2 mg/kg prior to the beginning of dental treatment at the first appointment. The alternative drug regimen was administered at the second appointment two weeks later. All subjects also received 50% nitrous oxide/oxygen during the treatment. The child's behavior: (1) sleeping; (2) crying; (3) body movement and (4) overall behaviors, was evaluated during injection and procedure by an independent clinician who was unaware of the drug given to the child.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138804092102N1
Registration date:2010-01-16, 1388/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-01-16, 1388/10/26
Registrant information
Name
Shahnaz Maghsoudi
Name of organization / entity
Hamadan university
Country
Iran (Islamic Republic of)
Phone
+98 21 4433 9369
Email address
sh.maghsoudi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical sciences
Expected recruitment start date
2007-10-23, 1386/08/01
Expected recruitment end date
2007-12-24, 1386/10/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the sedative effectiveness of oral combinations of midazolam/ketamine and midazolam /hydroxyzine in uncooperative pediatric dental patients
Public title
sedation in dentistry
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: uncooperative children, ages 37 to 56 months, in need of at least 2 restorative visits, parents acceptance.
Exclusion criteria: vomiting before or during treatment.
Age
From 3 years old to 5 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical sciences
Street address
Research affairs department - main building of Shiraz university of medical sciences - Zand street
City
Shiraz
Postal code
71345-1978
Approval date
2008-03-16, 1386/12/26
Ethics committee reference number
86-3904-CT
Health conditions studied
1
Description of health condition studied
Dentistry-related anxiety
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Conscious sedation
Timepoint
30 min in midazolam/ketamine group and 45 min in midazolam /hydroxyzine group
Method of measurement
observation-Houpt index
Secondary outcomes
empty
Intervention groups
1
Description
either the combination of midazolam 0.5 mg/kg and ketamine 5mg/kg or midazolam 0.5 mg/kg and hydroxyzine 2 mg/kg prior to the beginning of dental treatment
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz dentistry faculty
Full name of responsible person
Dr.Tahere Eskandarian
Street address
Pedodontic Department - Dentistry Faculty - Ghomabad Street - Ghasrodasht Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Mohammadhossein Dabbaghmanesh
Street address
Research affairs department - main building of Shiraz university of medical sciences-Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz university of medical sciences
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
Hamadan dentistry faculty
Full name of responsible person
Shahnaz Maghsoudi
Position
Assiatant professor-pedodontist
Other areas of specialty/work
Street address
Orthodontic Department-opposite of Mardom Park-Hamadan dentistry faculty-Hamadan
City
Hamadan
Postal code
65176-59114
Phone
+98 81 1835 4016
Fax
+98 81 1835 4220
Email
sh.maghsoudi@umsha.ac.ir, shm554@yahoo.com
Web page address
umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan dentistry faculty
Full name of responsible person
Shahnaz Maghsoudi
Position
Assiatant professor-pedodontist
Other areas of specialty/work
Street address
Orthodontic Departmenr-dentistry faculty-opposite of Mardom Park
City
Hamadan
Postal code
65176-59114
Phone
+98 81 1835 4016
Fax
+98 81 1835 4220
Email
sh.maghsoudi@umsha.ac.ir, shm554@yahoo.com
Web page address
www.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Shahnaz Maghsoudi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)