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Evaluation of Effectiveness of sodium diclofenac suppository in reduction of pain and dosage of narcotic in patients undergoing colonoscopy

Protocol summary

Summary
The aim of this study is to evaluate the effect of diclofenac suppository on dosage of narcotics during colonoscopy, in order to make sufficient tolerance to run a successful safety procedure and to obtain immediate consequence. This study will be done using 524 patients, after taking Informed consent, who candidate out-patient or in-patient colonoscopy for any reason. Patients with colonoscopy-phobia, history of previous intestinal surgery or inflammatory bowel disease or cardiopulmonary comorbidities or in conditions of contraindication of NSAIDs’ usage (e.g. hypersensitivity), will be excluded. This study is a prospective, randomized, single-blind, placebo controlled. Besides the same dug regiments of midazolam and fentanyl for both groups before colonoscopy, Diclofenac suppository was administered to case group 30 minute before procedure. According to each group, Duration of colonoscopy & Narcotic dosage which are used during colonoscopy, will be documented. At the end of colonoscopy, patients pain will be scored by nurse, using visual analogue scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092629976N1
Registration date: 2016-10-10, 1395/07/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-10, 1395/07/19
Registrant information
Name
Reza Mohseni Ahangar
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8301
Email address
r.mohseni@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research, Babol University Of Medical Sciences
Expected recruitment start date
2016-08-21, 1395/05/31
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effectiveness of sodium diclofenac suppository in reduction of pain and dosage of narcotic in patients undergoing colonoscopy
Public title
The effect of diclofenac suppository in the use of drugs to reduce pain in patients undergoing colonoscopy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:Colonoscopy candidate; consent to participate in the study Exclusion criteria:Patients who feared colonoscopy; patients with history of previous surgery; inflammatory bowel disease; cardiopulmonary comorbidities; history of NSAID hypersensitivity; in situation of their contraindication
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 526
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Babol University Of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol
City
Babol
Postal code
Approval date
2016-08-21, 1395/05/31
Ethics committee reference number
MUBABOL.REC.1395.130

Health conditions studied

1

Description of health condition studied
Acute pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain

Primary outcomes

1

Description
discomfort and pain
Timepoint
End of colonoscopy
Method of measurement
visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
In the Control group, (5 mg, Daroupakhsh company, Iran) and Fentanyl (500 µg, Daroupakhsh company, Iran) with adding placebo was prescribed.
Category
Treatment - Drugs

2

Description
In the intervention group, standard regimen include midazolam (5 mg, Daroupakhsh company, Iran) and Fentanyl (500 µg, Daroupakhsh company, Iran) with adding diclofenac suppository (100 mg, Daroupakhsh company, Iran) was prescribed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rouhani Hospital Of Babol
Full name of responsible person
Seyed Saeid Mohammadi Bonehi
Street address
Rouhani Hospital, Ganjafroz Street, Babol
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor For Research, Babol University Of Medical Sciences
Full name of responsible person
Ali Bijani
Street address
Babol University Of Medical Sciences, Ganjafrooz Street, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research, 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
Parviz Amri maleh
Position
Associated of Anesthesiolog
Other areas of specialty/work
Street address
Rouhani Hospital Of Babol, Ganjafrooz Street, Babol
City
Babol
Postal code
Phone
+98 11 3223 8284
Fax
Email
pamrimaleh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Seyed Saeid Mohammadi Bonehi
Position
Assistant Of Internal Medicine
Other areas of specialty/work
Street address
Rouhani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
47176-41367
Phone
+98 11 3223 8284
Fax
Email
ssmmbb293@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babaol University Of Medical Sciences
Full name of responsible person
Reza Mohseni Ahangar
Position
Resident Of Internal Disease
Other areas of specialty/work
Street address
Rouhani Hospital, Ganjafrooz Street, Babaol
City
Babaol
Postal code
47176-41367
Phone
+98 11 3223 8284
Fax
Email
rohanresearch88@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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