Comparison the effects and complications of paracetamol versus fentanyl for postoperative pain , and patient satisfaction after cataract surgery under topical anesthesia in Farabi Eye Hospital Tehran, Iran in 2011-2012
Cataract surgery is one of the most common types of eye surgeries performed around the world. Despite recent advantages in this procedure, post-operative pain management remains a significant problem. Acetaminophen is routinely used for controlling post-operative pain in several types of ocular surgery such as pan retinal photocoagulation, photorefractive keratotomy and cataract surgery and obtained promising results. To our knowledge, the comparison between Acetaminophen and fentanyl effect in reducing pain following cataract surgery has not been made yet, therefore this study was designed and conducted for filling this knowledge gap.
Methods: A double-blinded randomized clinical trial was initiated to compare the effect of paracetamol and fentanyl for post-operative pain management in cataract surgery in Farabi hospital in Tehran, Iran between 2011 and 2012. A total of 160 patients were enrolled and randomly assigned to receive either 15 mg/kg paracetamol(max: 1gr paracetamol in100 cc normal saline ) or fentanyl (1 µg/kg in 100 cc normal saline). All participants were given ringer's lactate solution (250 cc), midazolam (0.015mg/kg) and tetracaine (2 drops in eacheyes with interval of 5 minutes). At the end of study patients' pain, anxiety and satisfaction was assessed by a single anesthesiologist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012120511676N1
Registration date:2013-03-04, 1391/12/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-04, 1391/12/14
Registrant information
Name
Abbas Ostadalipour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8833 1595
Email address
a-ostadalipour@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sceinces
Expected recruitment start date
2013-02-18, 1391/11/30
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects and complications of paracetamol versus fentanyl for postoperative pain , and patient satisfaction after cataract surgery under topical anesthesia in Farabi Eye Hospital Tehran, Iran in 2011-2012
Public title
Comparison the effects and complications of paracetamol versus fentanyl for postoperative pain , patient satisfaction after cataract surgery under topical anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:. American Society of Anesthesiology=1-2; age=50-80 years and first time cataract surgery.
Exclusion criteria: addiction; psychological diseases; anxiety; existence of previous pain; sever allergic reaction; uncontrolled hepatic, renal and cardiovascular disease; neurologic disease;uncontrolled Diabetes Melitus disease and analgesic and sedative usage.
Age
From 50 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
tehran university medical sceince
Street address
Tehran University of Medical Sciences, Faculty of Medicine, Poursina Street, Tehran, Iran
Before sedation 3 times, 3 min after sedation 3 times
Method of measurement
Monitoring full parameter pyandehgan company
2
Description
Saturation arteial o2
Timepoint
Before sedation 3 times, 3 min after sedation 3 times
Method of measurement
Pulse oximetry
3
Description
Pain
Timepoint
Before sedation, recovery
Method of measurement
VAS score
4
Description
Mean arterial presure
Timepoint
Before sedation 3 times, 3 min after sedation 3 times
Method of measurement
Monitoring full parameter pyandehgan company
5
Description
Satisfaction
Timepoint
At the recovery room
Method of measurement
Score 0-10, 0=absent satisfaction, 10= max satisfaction
Secondary outcomes
1
Description
Apnea
Timepoint
During surgery
Method of measurement
Respiratory rate = 0
2
Description
Arrhythmia
Timepoint
During surgery
Method of measurement
Cardiac monitoring full parameter poyandehgan company
3
Description
Nausea and vomiting
Timepoint
At the recovery room
Method of measurement
Observation
Intervention groups
1
Description
Group 1 or intervention group or p: all participants were given midazolam 0.015 mg/kg and tetracain eye drop 2 drops in each eyes with interval of 5 minutes. Administered paracetamol (15 mg/kg) 1 g /100 cc normal salin/in 20 min stat.
Category
Treatment - Drugs
2
Description
Group2 or control group or F : all participants were given midazolam 0.015 mg/kg and tetracain eye drop 2 drops in each eyes with interval of 5 minutes. Administered fentanyl (1 µg/kg) in 100 cc normal salin intravenous / in 20 min stat
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
abbas ostadalipour, anesthesiologist, assistant professor
Street address
operation room Farabi hospital, south karegar, postal code 1336616351
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr Akbar Fotouhi
Street address
Ghods st. Cross, Keshavarz Bv
City
Tehran
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, Tehran University of Medical Sciences and Health Services
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
Tehran University of Medical Sceinces
Full name of responsible person
maryam jamshidi
Position
Anesthesiologist
Other areas of specialty/work
Street address
obstetric hospital, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8891 5353
Fax
Email
dr.mjamshidi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sceinces
Full name of responsible person
Abbas Ostadalipour
Position
Anesthesiologist
Other areas of specialty/work
Street address
Farabi hospital, Tehran University of Medical Sciences
City
Tehran
Postal code
1336616351
Phone
+98 21 5541 4104
Fax
Email
a-ostadalipour@tums.ac.ir
Web page address
www.farabihospital.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sceinces
Full name of responsible person
Abbas Ostadalipour
Position
Anesthesiologist
Other areas of specialty/work
Street address
Farabi hospital, Tehran University of Medical Sciences
City
Tehran
Postal code
1336616351
Phone
+98 21 5541 4104
Fax
Email
a-ostadalipour@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)