patients may experience mild, moderate to severe post endodontic pain. The aim of the present study is to investigate the role of alprazolam on the analgesic effect of Ibuprofen in post endodontic pain (PEP).
The exclusion criteria are:
Patients younger than 20 or older than 45 years old, Presence of systemic diseases, allergy to NSAIDs, taking sedative and other analgesics, pregnancy or breast feeding.
This double-blinded randomized clinical trial will be conducted in a three day periods.
The patients will be randomly allocated into control, Ibuprofen and Ibuprofen plus alprazolam groups. Fifteen patients will be entered in each group. The method is based on placebo- drug (Ibubrofen, Ibubrofen plus alprazolam) style. This study will be done in three days
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312219271N4
Registration date:2014-04-08, 1393/01/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-08, 1393/01/19
Registrant information
Name
Ali Akbar Moghadamnia
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1222 9591
Email address
a.moghadamnia@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Reserch Affairs of Babol University of Medical Sciences
Expected recruitment start date
2012-10-26, 1391/08/05
Expected recruitment end date
2013-10-27, 1392/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of pretreatment of alprazolam on stregthening of sedative impact of ibuprofen in patients suffering from the pain of root canal treatment.
Public title
Alprazolam role in the analgesic effect of ibuprofen on pain after root canal therapy.
Purpose
Treatment
Inclusion/Exclusion criteria
After providing adequate information to the subjects, eligible healthy volunteer will be enrolled in the study. Inclusion criteria: be healthy; normal dite; Non-inhibitor drugs.
Exclusion criteria: age below 20 and above 45; smoking; pregnancy; Breastfeeding.
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Ganj Afrooze Ave. University Sq.
City
Babol
Postal code
4717641376
Approval date
2013-07-02, 1392/04/11
Ethics committee reference number
2726
Health conditions studied
1
Description of health condition studied
Pharmacokietics
ICD-10 code
K04.9
ICD-10 code description
Other and unspecified diseases of pulp and periapical tissues
Primary outcomes
1
Description
Visual analog scale
Timepoint
4,6,12,24,48,72 hours after taking the medicine of regular intervals.
Method of measurement
Pain by visual assessment
Secondary outcomes
empty
Intervention groups
1
Description
Control group: administration placebo one capsule daily for three days.
Category
Other
2
Description
Alprazolam+Ibuprofen group: administration
Alprazolam+Ibuprofen(0.5mg+400mg) one capsule daily for three days.
Category
Treatment - Drugs
3
Description
Ibuprofen group: administration
Ibuprofen 400mg one capsule daily for three days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Moghadamnia
Street address
Department of Pharmacology, Faculty of Medicine, Babol University of Medical Sciences
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Ganje Afrooze Ave. University SQ.
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
DR. Ali Akbar Moghadamnia
Position
PharmaD,phD
Other areas of specialty/work
Street address
Ganje Afrooze Ave. University SQ.
City
Babol
Postal code
4717641367
Phone
+98 11 1219 2033
Fax
+98 21 92033
Email
moghadamnia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Moghadamnia
Position
pharmaD,PhD
Other areas of specialty/work
Street address
Ganje Afrooze Ave. University SQ.
City
Babol
Postal code
4717641367
Phone
+98 11 1219 2033
Fax
+98 21 92033
Email
Moghadamnia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Moghadamnia
Position
pharmaD.phD
Other areas of specialty/work
Street address
Ganje Afrooze Ave. University SQ.
City
Babol
Postal code
4717641367
Phone
+98 11 1219 2033
Fax
+98 21 92033
Email
moghadamnia@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)