1. Home
  2. Approved trials
  3. » فارسی

The study effect of intravenous acetaminophen in comparison with fentanyl on pain severity after Cataract surgery

Protocol summary

Study aim
Effect of intravenous acetaminophen and fentanyl on reduction of pain after cataract surgery
Design
Double blind randomized clinical trials
Settings and conduct
Patients with cataract surgery who will be referred to Farshchian Hospital in Hamadan in 2018.
Participants/Inclusion and exclusion criteria
Inclusion criteria: (a) patients with class 1 or 2 according to the American Society of Anesthesiology scoring criteria; (b) age of 25-55 years; (c) no history of psychotropic or opium drugs consumption. Exclusion criteria: (a) history of allergy to the drugs used in the plan; (b) disagreement with the patient's plan.
Intervention groups
50 patients receive 10 mg / kg acetaminophen per 100 ml of ringer serum for 20 minutes, and 50 patients will receive 1 microgram / kg intravenous 2 minutes before anesthesia induction.
Main outcome variables
Primary outcome: (a) severity of pain 1, 6, 12, 18, and 24 hours after surgery using visual analog scale (VAS); (b) opium dose (mg) usage 1, 6, 12, 18, and 24 hours after surgery; (c) hemodynamic status (blood pressure, heart rate) 1, 6, 12, 18, and 24 hours after surgery after surgery. Secondary outcome: (a) systemic side effects (nausea and vomiting); (b) urinary retention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120430009597N4
Registration date: 2018-07-07, 1397/04/16
Registration timing: registered_while_recruiting

Last update: 2018-07-07, 1397/04/16
Update count: 0
Registration date
2018-07-07, 1397/04/16
Registrant information
Name
Seyed Mohamad Zolhavarieh
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0020
Email address
sm.zolhavarieh@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study effect of intravenous acetaminophen in comparison with fentanyl on pain severity after Cataract surgery
Public title
The study effect of intravenous acetaminophen in comparison with fentanyl on pain severity after Cataract surgery in patients referring to Farshchian Hospital of Hamedan
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with class 1 or 2 according to the American Society of Anesthesiology scoring criteria no history of psychotropic or opium drugs consumption age of 25-55 years.
Exclusion criteria:
History of allergy to drugs used in the project Failure to agree to the project by the patient
Age
From 25 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The sample allocated to each of the two groups and the control block will be Block random permutation, with the fentanyl group (code A) and the acetaminophen group (code B) considered. Using random blocks of ABABBA 6 randomly selected samples are allocated to treatments. In this sample, the first person in the treatment group A is the second person in treatment B, the third in treatment A, the fourth in treatment B, the fifth in treatment B and the person The sixth treatment group A will receive the fentanyl group and the acetaminophen group. And this will continue to number of samples in groups. The next block will be as follows. AABABA, BABBAA, ABBABA, BBABAA, BABABA, BBABAA, ABABBA, BAAABB, BAABBA, ABBAB, BAABBA, BABAAB, BABABA, BBBAAA, BABAAB, ABBAAB.
Blinding (investigator's opinion)
Double blinded
Blinding description
A randomized, double blind clinical trial that the main author and patients are unaware of drugs groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-05-19, 1397/02/29
Ethics committee reference number
IR.UMSHA.REC.1397.097

Health conditions studied

1

Description of health condition studied
Cataract surgery
ICD-10 code
H59.9
ICD-10 code description
Postprocedural disorder of eye and adnexa, unspecified

Primary outcomes

1

Description
Pain severity
Timepoint
1, 6, 12, 18, and 24 hours after surgery
Method of measurement
Visual Analog Scale (VAS)

2

Description
Opium dose (mg) usage
Timepoint
1, 6, 12, 18, and 24 hours after surgery
Method of measurement
Medical record

3

Description
Hemodynamic status (blood pressure, heart rate)
Timepoint
1, 6, 12, 18, and 24 hours after surgery
Method of measurement
Physical examination

Secondary outcomes

1

Description
Nausea
Timepoint
2 hours after surgery
Method of measurement
Questionnaire

2

Description
Vomiting
Timepoint
2 hours after surgery
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: 50 patients in the fentanyl group will receive 1 microgram / kg intravenous 2 minutes before anesthesia induction.
Category
Treatment - Drugs

2

Description
Intervention group: In 50 patients, 10 mg / kg of acetaminophen was infused in 100 ml of ringer serum for 20 minutes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Seyed Mohammad Zolhavarieh
Street address
Shahid Fahmidah Street - Farshchian Hospital
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 1838 0749
Email
dsmbszolhavarieh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. saeid bashirian
Street address
Vice-chancellor of Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
38381035
Phone
+98 81 3838 1035
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Mohammad zolhavarieh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Beheshti Hospital, Eram Blv.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
dsmbszolhavarieh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Zolhavarieh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
dsmbszolhavarieh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Zolhavarieh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
dsmbszolhavarieh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...