Protocol summary

Summary
The purpose of this study is determine the level of patient’s satisfaction of upper gastrointestinal endoscopy using EMLA cream, EMLA gel, Lidocaine gel, Lidocaine spray and placebo gel and comparison the satisfaction of various groups together. This study design is double-blind clinical trial, considered population includes patients who under upper gastrointestinal endoscopy in Hajar hospital of Shahrekord. The number of patients studied is 150, they are randomly divided into 5 groups of 30 people, including (A, B, C, D and E). The EMLA cream are used five minutes before the endoscopy for Group A, EMLA gel for Group B, Lidocaine gel for group C, Lidocaine spray 1% (3 puffs in posterior part of the tongue) for group D and placebo gel group E that the cream and gel dose is 5 g in posterior part of the tongue for each patient, then patients undergoing upper gastrointestinal endoscopy. Inclusion criteria: upper gastrointestinal endoscopy in these patients should be a non-emergency; no history of upper gastrointestinal endoscopy. Exclusion criteria: age under 12 years; patients with acute gastrointestinal bleeding. Then primary outcome include the satisfaction of patients of endoscopy and secondary outcome include the pain and discomfort in the throat and neck area, the incidence of nausea, vomiting or retching will be examined during and up to half an hour after endoscopy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201509136480N9
Registration date: 2015-10-24, 1394/08/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-24, 1394/08/02
Registrant information
Name
Mohammad Taghi Moradi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
mtmoradi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahrekord University of Medical Sciences
Expected recruitment start date
2006-01-21, 1384/11/01
Expected recruitment end date
2006-06-22, 1385/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of prescription EMLA cream before endoscopy to reduce pain and increase the satisfaction of patients during and after endoscopy, with the effect EMLA gel, Lidocaine gel, Lidocaine spray and placebo gel in endoscopy patients
Public title
Determine the level of patient’s satisfaction of endoscopy using EMLA cream, EMLA gel, Lidocaine gel, Lidocaine spray and placebo gel
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: upper gastrointestinal endoscopy in these patients should be a non-emergency; the patients have given consent for endoscopy; no history of upper gastrointestinal endoscopy. Exclusion criteria: age under 12 years; lack of consent patient; patients with acute gastrointestinal bleeding; bedridden patients.
Age
From 12 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study sampling method is a table of random numbers.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Postal code
Approval date
2005-11-02, 1384/08/11
Ethics committee reference number
84-8-11

Health conditions studied

1

Description of health condition studied
Pain and dissatisfaction during upper gastrointestinal endoscopy
ICD-10 code
K90, K91,
ICD-10 code description
Other diseases of the digestive system

Primary outcomes

1

Description
The satisfaction of patients of endoscopy
Timepoint
During and after endoscopy
Method of measurement
GHAA-9 questionnaire

Secondary outcomes

1

Description
The pain and discomfort in the throat and neck area
Timepoint
During and after endoscopy
Method of measurement
GHAA-9 questionnaire

2

Description
Vomiting or retching evaluate
Timepoint
During and after endoscopy
Method of measurement
GHAA-9 questionnaire

Intervention groups

1

Description
Intervention group 1: The EMLA cream are used five minutes before the endoscopy for Group A (manufactured by AstraZeneca), the dose is 5 g in posterior part of the tongue.
Category
Treatment - Drugs

2

Description
Intervention group 2: The EMLA gel are used five minutes before the endoscopy for Group B (manufactured by AstraZeneca), the dose is 5 g in posterior part of the tongue.
Category
Treatment - Drugs

3

Description
Intervention group 3: The Lidocaine gel are used five minutes before the endoscopy for Group C (manufactured by AstraZeneca), the dose is 5 g in posterior part of the tongue.
Category
Treatment - Drugs

4

Description
Intervention group 4: The Lidocaine spray 1% are used five minutes before the endoscopy for Group D (manufactured by AstraZeneca), the dose is 3 puffs in posterior part of the tongue.
Category
Treatment - Drugs

5

Description
Intervention group 5: The placebo gel are used five minutes before the endoscopy for Group E (manufactured by AstraZeneca), the dose is 5 g in posterior part of the tongue.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar hospital of Shahrekord
Full name of responsible person
dr Jafar Nasiri
Street address
Hajar hospital, Parastar Street, Shahrekord
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mahmoud Mobasheri
Street address
Vice Chancellor for research, Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
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, Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
dr Jafar Nasiri
Position
Gastroenterologist
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 2907
Fax
Email
jhnasiri@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
dr Jafar Nasiri
Position
Gastroenterologist
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
shahrekord
Postal code
Phone
+98 38 3333 2907
Fax
Email
jhnasiri@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
dr Jafar Nasiri
Position
Gastroenterologist
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 2907
Fax
Email
jhnasiri@yahoo.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
Loading...