Phentolamine mesylate effect on duration of soft tissue local anesthesia and incidence of soft tissue trauma after mandibular injection in children in 4-6 years of age
Phentolamine mesylate(PM) is antagonist of epinephrine and reduces duration of numbness of soft tissue after injection of local anesthesia. We evaluate the phentolamine mesylate effect on reversal time of normal sensation and trauma to the soft tissue after mandibular block injection in patient of 4-6 years of age.
In this randomized double blind controled clinical trial 54 pediatric patients have been devided in two groups and after describing the process of this study to their parents(approved by medical sciences),
in group 1 in the first visit, 30 minutes after local anesthesia injection, PM has been injected; in the second visit in this group patients receive local anesthesia injection without PM injection. In contrast the group 2 in the first visit receive a control injection(sham injection in which a needle does not penetrate the tissue) and in the second visit receive PM after local anesthesia. We evaluate reversal time of normal sensation of soft tissue every 15 minutes by soft tapping with index finger and also we assess the vital sign, incidence of trauma to soft tissue for 3-5 hours and patients have been followed for at least 48 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102285934N1
Registration date:2012-05-17, 1391/02/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-17, 1391/02/28
Registrant information
Name
Mahdi Babaei
Name of organization / entity
Isfahan University of Medical Sciences-Dentistry college
Country
Iran (Islamic Republic of)
Phone
+98 31 1788 3314
Email address
babaei@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-04-09, 1390/01/20
Expected recruitment end date
2012-06-04, 1391/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Phentolamine mesylate effect on duration of soft tissue local anesthesia and incidence of soft tissue trauma after mandibular injection in children in 4-6 years of age
Public title
Phentolamine mesylate effect on duration of soft tissue local anesthesia and incidence of soft tissue trauma after local anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: systematically healthy children who require routine dental treatment without alergies or intolerance to anesthetics, epinephrine, sulfites
patient that requires bilateral dental procedure except extraction(2%lidocaine with 1/80000 epinephrine) andhaving weight equal or greater than 15kg.
Exclusion criteria: patient requires more than 1 cartrdge of lidocain with 1/80000 epinephrine or another local anesthetic, sedation, lesser than 15kg and younger than 4 years of age.
Age
From 4 years old to 6 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan university of medical sciences
Street address
Isfahan university of medical sciences-Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2011-03-12, 1389/12/21
Ethics committee reference number
390348
Health conditions studied
1
Description of health condition studied
The effectiveness ofphentolamine mesylate on the adverse effect of local anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
The effectiveness of phentolamine mesylate on the reduction of reversal time of numbness of soft tissue
Timepoint
15 minutes
Method of measurement
A soft tapping by index finger to the trained children
2
Description
Trauma to soft tissue
Timepoint
Every 30 minutes
Method of measurement
Inspection
Secondary outcomes
1
Description
The probability of change in the blood pressure
Timepoint
Every 30 minutes
Method of measurement
Digital sphygmomanometer
Intervention groups
1
Description
Injection of phentolamine mesylate for pediatrics who weighted 15 kg or more and less than 30 kg receive one-half cartridge of anesthetics.Those weighing 30 kg or more received wole cartridge- Phentolamine injection perform 30 minutes after injection of local anesthesia-Trade name of drug is Oraverse
Category
Treatment - Drugs
2
Description
In control group, we apply the sham injection(needle does note penetrate the tissue) in the same side that local anesthesia has been injected.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
The pediatric department, Faculty of dentistry, Isfahan University of Medical Sciences