Efficacy of baclofen 5% cream in the reduction of postoperative pain after open hemorrhoidectomy: a prospective, double-Blind, randomized, placebo controlled clinical trial
The object of this study is to evaluate the efficacy of topical baclofen in relieving post hemorrhoidectomy pain through a double-blind, randomized, placebo controlled trial. Sixty numbers of patients that have hemorrhoidectomy surgery are enrolled in the study. Individuals who show hypersensitivity to the product or taking oral baclofen are excluded from study. Patients will receive acetaminophen tablets as oral treatment and baclofen or placebo cream twice daily for one month. Pain intensity is measured by visual analog scale and recorded weekly after surgery. Side effects of product and the process of wounds healing during intervention are evaluated and recorded by the questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609163014N16
Registration date:2017-01-07, 1395/10/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-07, 1395/10/18
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of baclofen 5% cream in the reduction of postoperative pain after open hemorrhoidectomy: a prospective, double-Blind, randomized, placebo controlled clinical trial
Public title
Efficacy of topical baclofen in the reduction of postoperative
pain after hemorrhoidectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20 and 70 years; candidate for hemorroidectomy surgery
Exclusion criteria: Hypersensivity to baclofen; develop ulcer size; taking oral baclofen
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is done using random number table.
We give a code number to each patient that shows the group each patient is allocated to. The list of patients and their code numbers is kept secret until the end of the trial. In this way neither the patient nor the researchers know whether it is drug or placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University Medical Sciences
Street address
Moalem Sq.
City
Sari
Postal code
Approval date
2016-09-20, 1395/06/30
Ethics committee reference number
IR.Mazums.Rec.95-2624
Health conditions studied
1
Description of health condition studied
hemorrhoids
ICD-10 code
I84.4
ICD-10 code description
External haemorrhoids with other complications
Primary outcomes
1
Description
Pain intensity
Timepoint
7th, 14th, 21th, 28th day after surgery
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Side effects
Timepoint
7th, 14th, 21th, 28th day after surgery
Method of measurement
Questionnarie
Intervention groups
1
Description
Intervention: Baclofen 5% cream, twice daily until one month plus acetaminophen 325 mg tablets three times daily
Category
Treatment - Drugs
2
Description
Control: Placebo cream, without active ingredient, twice daily until one month plus acetaminophen 325 mg tablets three times daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital and educational center
Full name of responsible person
Dr. Shahram Ala
Street address
Payambar azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy, Km 20 Khazar abad Road
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmadali Enayatifar
Street address
Payambar Azam University Complex, Mazandaran University of Medical Sciences, Km 20 Khazar Abad Road
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Mazandaran 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
Mazandaran University of Medical Science, Faculty of Pharmacy
Full name of responsible person
Dr Shahram Ala
Position
Clinical pharmacy specialist, Associated professor
Other areas of specialty/work
Street address
Payambar Azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy, Km 20 Khazar Abad Road
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
sala@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Science, Faculty of Pharmacy
Full name of responsible person
Dr Shahram Ala
Position
Clinical pharmacy specialist, Associated professor
Other areas of specialty/work
Street address
Payambar azam University Complex, Mazandaran University of Medical Sciences, Faculty of pharmacy, Km 20 Khazar abad Road
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
Sala@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Science, Faculty of Pharmacy
Full name of responsible person
Mahila Monajati
Position
Resident of clinical pharmacy
Other areas of specialty/work
Street address
Payambar azam University Complex, 20 km khazar abad Road
City
Sari
Postal code
Phone
00
Fax
Email
mahilamonajati@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)