The purpose of this study is to evaluate the effect of Dexmedetomidine plus Bupivacaine on postoperative pain in mandibular third molars surgery.
Design
Double blind randomized clinical trial with control group.60 patient between October 2019 and October 2020
Settings and conduct
This study is performed at Shahid Beheshti Dental School. Patients are asked for pain by visual analogue scale 4, 8 and 12 hours after surgery (mild: 1-3 moderate: 4-6 sever 7-10)and also taking or not taking Ibuprofen during the next 12 hours, if taken analgesic, it is classified as severe pain.
Participants/Inclusion and exclusion criteria
Patients undergoing Class B-2 mandibular third molar surgery with ASA status I and age range 18 to 36 years who are referred to Shahid Beheshti Dental School enter the study and patients with drug addiction and using psychological drugs and have tooth decay in the study quadrant or the female patients in the menus period are excluded.
Intervention groups
Sixty patients in the study are divided equally into two groups. Both groups undergo impacted third molar removal. Both groups receive 400 mg ibuprofen one hour before surgery. In the intervention group, inferior mandibular block injection with Bupivacaine% 0/5 and Epinephrine 1: 200000 with 0.5 mg / kg Dexmedetomidine is injected after completion of surgery. In control group injection of inferior mandibular block injection with 1.8 ml Bupivacaine 0.5% with epinephrine 1: 200000 after Surgery is performed but Dexmedetomidine is not injected.
Main outcome variables
Patients degree of pain at 4, 8, and 12 hours after surgery and taking or not taking Ibuprofen during 12 hours after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190819044566N1
Registration date:2019-09-18, 1398/06/27
Registration timing:prospective
Last update:2019-09-18, 1398/06/27
Update count:0
Registration date
2019-09-18, 1398/06/27
Registrant information
Name
Pegah Mehrabi nia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4441 8360
Email address
pegahmehrabinia@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Dexmedtomidine plus Bupivacaine on postoperative pain in mandibular third molar Surgery.
Public title
Effect of Dexmedtomidine on postoperative pain in third molar surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with impacted wisdom tooth (Mesioangular, class II B in Pel and Gregory classification)
18 to 30 years old
ASA I status
Referred to Shahid Beheshti Dental School for Surgery and willing to be enrolled in the study
Exclusion criteria:
Patients who receive psychological drugs or have drug addiction
More than one tooth surgery or other dental treatments such as root canal therapy
Impact tooth in other categories of Pel and Gregory classification
Refuse to study enrollment
Women in menses
Age
From 18 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random allocation software was used for simple randomization.after allocation in 2 groups with 20 persons, concealed in sequentially numbered, sealed, opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
After informing patients of their study and consenting to this study, they are divided into two groups to reduce bias for intervention and outcome evaluation in a double-blind manner so that patients are divided into two groups of one and two without knowledge of membership in which group, they receive surgery. Neither the study nor the observer knows who will be in which group.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University Of Medical Sciences, A'arabi St., Daneshjou Blv., Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1469733476
Approval date
2017-10-29, 1396/08/07
Ethics committee reference number
IR.SBMU.RIDS.REC.1396.573
Health conditions studied
1
Description of health condition studied
Post dental surgery pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Post surgical pain
Timepoint
4, 8, 12 hours after surgery
Method of measurement
The pain severity is measured using visual analogue scale by asking patients: 0-10 (0-3 mild, 4-6 moderate and 7-10 sever which subjects need pain relief drugs).
2
Description
The amount of analgesics that is used by patients
Timepoint
Consumption of analgesic within 12 hours after surgery
Method of measurement
Asking patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: subjects receive a mixture of Bupivacaine 0.5% (1.8 ml) with epinephrine 1:200000 (Novocal Pharmucautical of Canada Inc. Cambridye, Ontario N1R6) and 0.5 mg/kg Dexmedetomidine (Exir co, Iran) through the inferior alveolar nerve block injection and immediately after surgeries.All subjects receive 400 mg Ibuprofen 1 hour before surgeries.
Category
Treatment - Drugs
2
Description
Control group:1.8 ml Bupivacaine 0.5% and Epinephrine 1:200000 is injected after surgeries for all subjects. All subjects receive 400 mg Ibuprofen 1 hour before surgeries.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti dental school
Full name of responsible person
Hasan Mir Mohammad Sadeghi
Street address
Shahid Beheshti University of Medical Sciences, A’arabi St., Daneshjou Blv., Velenjak, Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
1469733476
Phone
+98 21 4441 8390
Email
Pegahmehrabinia@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pegah Mehrabi Nia
Street address
Shahid Beheshti University of Medical Sciences, A’arabi St., Daneshjou Blv., Velenjak, Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
1469733476
Phone
+98 21 4441 8390
Email
pegahmehrabinia@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pegah Mehrabi Nia
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti University of Medical Sciences, A’arabi St., Daneshjou Blv., Velenjak, Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
1469733476
Phone
+98 920 510 6983
Email
pegahmehrabinia@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pegah Mehrabi Nia
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti University of Medical Sciences, A’arabi St., Daneshjou Blv., Velenjak, Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
1469733476
Phone
+98 920 510 6983
Email
pegahmehrabinia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pegah Mehrabi Nia
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti University of Medical Sciences, A’arabi St., Daneshjou Blv., Velenjak, Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
1469733476
Phone
+98 920 510 6983
Email
pegahmehrabinia@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available