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Comparison of efficacy IV Ketorolac and Indomethacin to prevention post ERCP pancreatitis and hyperamylasemia in pateints under going ERCP

Protocol summary

Study aim
Comparison of the efficacy intravenous ketorolac and indomethacin suppositories in the prevention of acute pancreatitis and hyperamylasmia after Endoscopic retrograde cholangiopancreatography
Design
This study was a randomized clinical trial designed for two parallel armies, double blind and single center. The study group is for all men and women 18 to 85 years of age who have an indication of Endoscopic retrograde cholangiopancreatography. Randomization is done using Win Pepi software. The number of samples in each group is 18 and in total 36 will be.
Settings and conduct
Patients are randomly entered into one of the two arms of the study, including the intervention arm and the control arm, and will be treated with indomethacin suppository or venous ketorolac. Post-Endoscopic retrograde cholangiopancreatography examinations are done at intervals of 2, 12, and 24 hours, including blood samples for serum amylase and lipase examination, examination of the patient in terms of abdominal pain, Visual Analog Scale, dose and dose of pethidine used, vital signs, nausea and vomiting is. Patients will be monitored for ketorolac and indomethacin for digestive and renal complications.
Participants/Inclusion and exclusion criteria
all men and women 18 to 85 years of age who have an indication of Endoscopic retrograde cholangiopancreatography. exclusion : Recent Acute pancreatitis and contraindication for the use of Nonsteroidal Anti Iinflammatory Drugs
Intervention groups
the first group included treatment with riger lactate serum during Endoscopic retrograde cholangiopancreatography( ERCP)and 8 hours later with indomethacin suppository. In the other arm, In addition to standard hydration, 30 mg intravenous ketorolac is injected .
Main outcome variables
Age of sex,creatinine clearance, underlying diseases, Hyperamylasmia, Hyperlipazemy, Pethidine dose, Pancreatitis severity, Pain rate, Mortality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190420043330N1
Registration date: 2020-03-30, 1399/01/11
Registration timing: retrospective

Last update: 2020-03-30, 1399/01/11
Update count: 0
Registration date
2020-03-30, 1399/01/11
Registrant information
Name
Navid Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4233 0086
Email address
n.hosseini@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-15, 1398/02/25
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy IV Ketorolac and Indomethacin to prevention post ERCP pancreatitis and hyperamylasemia in pateints under going ERCP
Public title
Effect of IV Ketorolac to prevention post ERCP pancreatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Indication of ERCP
Exclusion criteria:
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Use Win Pepi
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patients, nurse , supervisor and researcher don't know which group of patients will use the ketorolac or indomethacin . Physician and clinicians team know about the drug and group who use the drug.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Dept of research Qazvin University of Medical Sciences Shahid Beheshti, Ave Qazvin' IRAN
City
Qazvin
Province
Qazvin
Postal code
1391134156
Approval date
2019-05-12, 1398/02/22
Ethics committee reference number
IR.QUMS.REC.1398.030

Health conditions studied

1

Description of health condition studied
post ERCP pancreatitis
ICD-10 code
K85
ICD-10 code description
Acute pancreatitis

Primary outcomes

1

Description
rate of Acute Pancreatitis Post Ercp
Timepoint
At intervals 2, 12 and 24 hours after ERCP, blood samples are taken to check serum amylase and lipase.
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The standard treatment was ridge-ralctate serum hydration at a rate of 1.5cc / kg / h during ERCP and eight hours after receiving indomethacin suppository rectal immediately after ERCP.
Category
Treatment - Drugs

2

Description
Intervention group: The standard treatment was hydrating with Ringer Lactate serum at 1.5cc / kg / h during ERCP and eight hours later, and 30 mg intravenous ketorolac immediately after ERCP.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vellayat hospital
Full name of responsible person
Navid Hosseini
Street address
22nd Bahman
City
Qazvin
Province
Qazvin
Postal code
02833790610
Phone
+98 28 3379 0620
Email
N.hosseini@qums.ac.ir
Web page address
Http://hosvelayat.qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir peymani
Street address
Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 3333 7006
Email
Research.dpt@qums.ac.ir
Web page address
Http://vcr.qums.ac.ir/Portal/Home/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Navid Hosseini
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Vahid Pharmacy ,Shohada Avn
City
Lahijan
Province
Guilan
Postal code
0000000000
Phone
+98 13 4233 0086
Email
n.hosseini@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Navid Hosseini
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Vahid Pharmacy, Shohada Avn
City
Lahijan
Province
Guilan
Postal code
000000000
Phone
+98 13 4233 0086
Email
N.hosseini@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Navid Hosseini
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Vahid Pharmacy, Shohada Avn
City
Lahijan
Province
Guilan
Postal code
00000000
Phone
+98 13 4233 0086
Email
N.hosseini@qums.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
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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