The effect of Diltiazem gel in camparison with Lidocaine gel on the pain parameter in rectosigmoidoscopy without sedation
Design
In this research, 80 eligible patients needed rectosigmoidoscopy referring to Qom gastroenterology clinic were chosen. Then, patients by block randomization were randomly divided into two control and intervention groups.
Settings and conduct
The study was performed as a randomized clinical trial at Shahid Beheshti Hospital in Qom. The study is double-blinded, and intervention is conducted by someone other than the care provider, and care provider and participants is unaware of the type of treatment.
Participants/Inclusion and exclusion criteria
People entering the study aged 18 to 40 years and patients who have need general anesthesia were not included in the study
Intervention groups
Intervention group will receive the Diltiazem gel, 2cc, once, 5 minutes before rectosigmoidoscopy, rectal injection and control group will receive Lidocaine gel, 2cc, once, 5 minutes before rectosigmoidoscopy, rectal injection
Main outcome variables
Pain scale during rectosigmoidoscopy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161205031252N6
Registration date:2018-05-26, 1397/03/05
Registration timing:registered_while_recruiting
Last update:2018-05-26, 1397/03/05
Update count:0
Registration date
2018-05-26, 1397/03/05
Registrant information
Name
Ahmad Hormati
Name of organization / entity
Qom university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2053
Email address
hormatia@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Diltiazem gel in camparison with Lidocaine gel on the pain parameter in rectosigmoidoscopy without sedation
Public title
The effect of Diltiazem gel and Lidocaine gel on the pain of rectosigmoidoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 40 years
Need to rectosigmoidoscopy
Would like to participate in the study
Exclusion criteria:
Anal fissure
Need general anesthesia
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization at the level of the individual
Blinding (investigator's opinion)
Double blinded
Blinding description
participants and the therapist does not know the allocation of people, and only the person who supplies the medication to the patients is aware of the type of allocation
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences