Determination of analgesic effect of oral oxycodone and intravenous fentanyl in patients undergoing colonoscopy
Design
A randomized, double-blind, three-phase, randomized clinical trial performed on 80 patients at random.
Settings and conduct
The studied population are patients aged 18-69 years who are candidates for colonoscopy, referring to Ayatollah Rohani Medical Training Center of Babol. The patients are randomly divided into two intervention groups using the random number table method and the intervention is performed on them.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Consent to participate in the study; colonoscopy candidate;The American Society of Anesthesiologists (ASA) class I&II and Age 18-69 years old
Exclusion Criteria: Decreased level of consciousness GCS less than 15; History of drug addiction; Hemodynamic instability and Mental disorder
Intervention groups
Intervention group: patients receive slow-release oral oxycodone (Faroxi company) with a dose of 30 mg one hour before the start of the colonoscopy, then enter the room after one hour, and after monitoring and 5 minutes before the start of the colonoscopy, one cc Normal intravenous saline is prescribed.
Control group: patients receive placebo capsules one hour before the start of colonoscopy, then enter the room after one hour, and after entering the room and monitoring, they receive 50 micrograms of intravenous fentanyl (Caspian) (one cc).
0.5 to 1 ml per body weight of propofol (Caspian Company) was administered intravenously to both groups.
Main outcome variables
intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111010007752N13
Registration date:2022-10-14, 1401/07/22
Registration timing:registered_while_recruiting
Last update:2022-10-14, 1401/07/22
Update count:0
Registration date
2022-10-14, 1401/07/22
Registrant information
Name
Parviz Amri Maleh
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
pamrimaleh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-02, 1401/07/10
Expected recruitment end date
2023-03-30, 1402/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effects of oral oxycodone and intravenous fentanyl in patients undergoing lower gastrointestinal colonoscopy
Public title
Analgesic effect of oral oxycodone and intravenous fentanyl in patients undergoing colonoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The American Society of Anesthesiologists (ASA) class I&II (Grade 1: No cardiovascular, respiratory, glandular and Grade 2: Controlled diabetes)
Age 18-69 years old
Colonoscopy candidate
Consent to participate in the study
Exclusion criteria:
Decreased level of consciousness GCS less than 15
History of drug addiction
Hemodynamic instability
Mental disorders
Age
From 18 years old to 69 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done using permuted blocks of size 4. (AABB) in such a way that blocks of 4 consist of random combinations of 2 A (Oxycodone) and 2 B (Fentanyl). It will be allocated to two groups of 40 people. Creating a random sequence in the blocks will be done by a statistician.
Blinding (investigator's opinion)
Double blinded
Blinding description
Oxycodone is in capsule form. For the purpose of blinding, capsules containing placebo are chosen to be the same shape as oxycodone capsules, so that they are completely similar in terms of smell, color and shape.
Capsules containing oxycodone and placebo are placed in cans of the same shape and size, and then a code will be written on each can. After the patient enters the study, one of these cans will be assigned to the patient and the code on the can will be written on the patient's file (study checklist), while the researcher does not know the contents of the can and the codes. Opening the codes will be done after completing the study.
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 Siences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2022-08-15, 1401/05/24
Ethics committee reference number
IR.MUBABOL.REC.1401.084
Health conditions studied
1
Description of health condition studied
Acute pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
intensity of pain
Timepoint
during colonoscopy
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receive slow-release oral oxycodone (Faroxi company) with a dose of 30 mg one hour before the start of the colonoscopy, then after one hour they enter the room, and after monitoring and 5 minutes before the start of the colonoscopy, 1 cc Normal saline intravenous saline is prescribed.
Category
Treatment - Drugs
2
Description
Control group: patients receive placebo capsules one hour before the start of colonoscopy, then enter the room after one hour, and after entering the room and monitoring, they receive 50 micrograms of intravenous fentanyl (Caspian) (1 cc).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Parviz Amri
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
p.amrimaleh@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
mehdi rajabnia
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
m.rajabnia@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?