The aim of this study was to compare four types of medication in patients undergoing colonoscopy will be satisfaction and pain control. In this single-blind clinical trial and in a period of six months,164 patients under the elective colonoscopy that inclusion criteria of at least 18 years of age non-emergency surgery and colonoscopy and without lack of acute bleeding in patients would be. If the patient needs more drug at the time of the colonoscopy, patient will excluded from the study. Patients in 4 groups as follows: Group A (N = 41) patients receiving midazolam and fentanyl, Group B: (N = 41) patients receiving hydroxyzine and fentanyl, Group C: (N = 41) patients receiving Ktrvlak, group D: (N = 41) patients receiving fentanyl and will be Ktrvlak. The primary outcome of Pain and satisfaction during and immediately after colonoscopy with VAS scale and GHAA- 9 scale collected and will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112221806N2
Registration date:2016-03-12, 1394/12/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-12, 1394/12/22
Registrant information
Name
Abolfazl Abdollahpoor
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 532 6300
Email address
abolfazlabdollahpoor@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences - Research and development Vice
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison among four metods of medication administration on pain control and satisfaction patients undergoing colonoscopy
Public title
pain control and satisfaction patients undergoing colonoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria :Non urgency of colonoscopy؛At least 18 years of age for participant؛Patient satisfaction؛The lack of acute gastrointestinal bleeding؛The patient is placed first under colonoscopy.
Exclusion criteria:If the patient needs more medication at colonoscopy time؛Sensitivity to patients' medication.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
164
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Kosar hospital in Semnan
City
semnan
Postal code
Approval date
2015-12-01, 1394/09/10
Ethics committee reference number
ir.semums.rec.1394.112
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R10.3
ICD-10 code description
Pain localized to other parts of lower abdomen
Primary outcomes
1
Description
Pain patients-Patient satisfaction
Timepoint
6 months
Method of measurement
standard questionnaires VAS and GHAA- 9
2
Description
Patients' satisfaction
Timepoint
6 months
Method of measurement
standard questionnaires VAS and GHAA- 9
Secondary outcomes
empty
Intervention groups
1
Description
In the group A used of drugs (midazolam + fentanyl) 2 mg/kg bolus intravenous fentanyl and midazolam 0.03 mg/kg as a bolus.
Category
Treatment - Drugs
2
Description
In the group B is used the drug (hydroxyzine + fentanyl) so that consumed two hours before colonoscopy, two tablets of 25 mg hydroxyzine and fentanyl 2 mg / kg intravenous bolus.
Category
Treatment - Drugs
3
Description
In the group C is injected intravenously drugs (ketorolac) so that 30 minutes before the colonoscopy 0.5mg / kg.
Category
Treatment - Drugs
4
Description
In the group D is injected intravenously drugs (ketorolac+ fentanyl) so that bolus intravenous fentanyl of 2 mg/kg, 30 minutes before the colonoscopy ketorolac 0.5 mg/kg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar hospital
Full name of responsible person
Abolfazl Abdollahpor
Street address
Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Department of Surgery Kowsar hospital
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Alireza Dabiri
Position
gastroenterologist
Other areas of specialty/work
Street address
Department of Surgery Kowsar hospital
City
Semnan
Postal code
Phone
+98 23 3343 7821
Fax
Email
dabirirzf@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abolfazl Abdollahpoor
Position
Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology Kowsar hospital
City
Semnan
Postal code
Phone
+98 23 3343 7821
Fax
Email
abolfazlabdollahpoor@semums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elahe Jahan
Position
Master of Nursing
Other areas of specialty/work
Street address
Department of Surgery Kowsar hospital
City
semnan
Postal code
Phone
00
Fax
Email
elahe.jahan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)