Determination of Effect of Diclofenac Suppository with Acetaminophen Suppository on Reducing Pain following Hemorrhoidectomy
Design
Clinical trials have two groups, parallel groups, patients who are candidates for hemorrhoidectomy, randomized Double blinded
Settings and conduct
The study would be held in Imam Ali hospital, Zahedan for patients who are candidates for hemorrhoidectomy.
The study is double blind as the investigator and the patients will not be aware of the suppository types.
Participants/Inclusion and exclusion criteria
Inclusion citeria: All patients undergoing hemorrhoidectomy in Imam Ali Hospital, Zahedan/
ٍExclusion criteria: History of coagulation disorder, Daily oral intake of NSAID, Alcohol or drug abuse, obvious liver or alcoholic diseases, Asthma, Chronic obstructive pulmonary disease, History of peptic ulcer
Intervention groups
The groups are divided into two groups: the first group takes 2 doses of 325 mg of acetaminophen suppositories which is 650 mg and the second group of diclofenac suppositories is 100 mg.
Main outcome variables
Amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190128042525N2
Registration date:2019-04-27, 1398/02/07
Registration timing:retrospective
Last update:2019-04-27, 1398/02/07
Update count:0
Registration date
2019-04-27, 1398/02/07
Registrant information
Name
Gholamreza Bazmandegan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0185
Email address
clinical.research@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-06-02, 1393/03/12
Expected recruitment end date
2016-12-02, 1395/09/12
Actual recruitment start date
2014-11-07, 1393/08/16
Actual recruitment end date
2017-01-14, 1395/10/25
Trial completion date
2017-03-06, 1395/12/16
Scientific title
Comparing the effect of diclofenac and acetaminophen suppositories in decrease pain following hemorrhoidectomy
Public title
Diclofenac and acetaminophen in hemorrhoidectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients undergoing hemorrhoidectomy in Imam Ali Hospital
Exclusion criteria:
History of coagulation disorder
Daily oral intake of NSAID
Alcohol or drug abuse
liver or alcoholic disease
Asthma
Chronic obstructive pulmonary disease
History of peptic ulcer
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Selection and assignment of samples to each treatment group will be done by random blocking method. Therefore, according to the sample size of 70 cases, 9 blocks were defined with 8 patients per block which are equally placed in each block of the groups. Then the tabs are arranged for each of the groups according to the random distribution in each block. So, upon completion of each block, 8 patients will be enrolled in the study, which will be equal to 4 patients from each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The investigator and Data analyzer will not be informed of the type of study group (type of suppository that will be consumed in each group). At the beginning of the study, all participants will be given study conditions and the two types of drugs which will be used, but none of them will be aware in which group they will be assigned.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
ZAUMS Main campus, Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2013-12-31, 1392/10/10
Ethics committee reference number
IR.Zaums.REC.1392.967
Health conditions studied
1
Description of health condition studied
hemorrhoidectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Amount of pain
Timepoint
Zero times (recovery) 2.4, 12 24 hours after the patient's operation
Method of measurement
Visual analogue score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: two suppositories of acetaminophen 325 mg equal to 650 mg.
Category
Treatment - Drugs
2
Description
Intervention Group 2: Diclofenac suppository 100 mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali_Ibne_ Abitaleb Hospital
Full name of responsible person
Ismail Elahabadi
Street address
Salamat Blvd., Khalij-e-Fars Highway, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
elahabadi.dr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ismail Elahabadi
Street address
ZAUMS Main campus, Khalij_e_Fars Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Fax
+98 54 3329 5796
Email
research@zaums.ac.ir
Web page address
http://www.zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Ismail Elahabadi
Position
General Surgeon, Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ali Ibn-Abitaleb Blvd., Ali Ibn-Abitaleb Hospital, Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Fax
Email
clinical.research@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ismail Elahabadi
Position
General Surgeon, Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ali Ibn-Abitaleb Blvd., Ali Ibn-Abitaleb Hospital, Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Fax
Email
clinical.research@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ismail Elahabadi
Position
General Surgeon, Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ali Ibn-Abitaleb Blvd., Ali Ibn-Abitaleb Hospital, Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Fax
Email
clinical.research@rums.ac.ir
Web page address
https://rums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD