Evaluation of administration effects of intravenous acetaminophen on postoperative pain, nausea and sedation score in vitroretinal surgery with generall anesthesia
Pain is one of the most important complications of surgeries. Pain increases complications, recovery time and costs.
This study evaluates the preemptive effect of intravenous acetaminophen to control pain, nausea, vomiting, shivering in patients undergoing viteroretinal surgery with general anesthesia. This study evaluated 83 patients referred to the Farabi hospital in 1392. Inclusion criteria was age between 18 to 70 years. Exclusion criteria were opioid use within past 48 hours and neurologic diseases.
Patients were randomly divided into 3 groups:
Control group (41 patients) received 100 milliliter of normal saline as placebo on 20 minutes before surgery and 20 minutes prior to the end of the surgery.
Preemptive group (21 patients) received 15 milligram/ kilogram of acetaminophen in 100 milliliter normal saline 20 minutes before surgery and 100 milliliter normal saline 20 minutes before the operation ending.
Preventive group (21 patients) received 100 milliliter normal saline intravenously 20 minutes before surgery and 15 milligram/ kilogram acetaminophen in 100 milliliter normal saline 20 minutes before end of surgery.
Pain scores in recovery, 2 and 4 hours after surgery in the control group were significantly higher than the other two groups. Twenty four hours after surgery, pain scores were not significantly different in the 2 groups. Analgesics consumption was significantly greater in the control group. Nausea, vomiting and shivering were not significantly different between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311139213N3
Registration date:2014-05-12, 1393/02/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-12, 1393/02/22
Registrant information
Name
Jalil Makarem
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1576
Email address
j-makarem@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of administration effects of intravenous acetaminophen on postoperative pain, nausea and sedation score in vitroretinal surgery with generall anesthesia
Public title
Evaluation of preemptive effects of intravenous acetaminophe in viteroretinal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Age between 18 to 70 years
exclusion criteria: opioid use within past 48 hours; psychological and neurologic disease; sever heart disease; sever liver disease; sever kidney disease; hematologic disease; metabolic and physical disease; history of chronic pain;
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
83
Randomization (investigator's opinion)
Randomized
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
Ethics Committee of Tehran university of medical sciences
Street address
Ghods street, keshavars boulevard
City
Tehran
Postal code
Approval date
2013-09-28, 1392/07/06
Ethics committee reference number
1427 / 130 / ص / 92
Health conditions studied
1
Description of health condition studied
Vitreoretinal surgery
ICD-10 code
H35
ICD-10 code description
Other retinal disorders
Primary outcomes
1
Description
pain
Timepoint
recovery, 2h after surgery.4h after surgery.24h after surgery
Method of measurement
Pain from 1 to 10 based on VRS score will be recorded
Secondary outcomes
1
Description
nausa
Timepoint
ricovery, 2h after surgery,4 hour after surgery, 24h surgery
Method of measurement
Its presence or absence is recorded
2
Description
vomit
Timepoint
ricovery, 2h after surgery,4 hour after surgery, 24h surgery
Method of measurement
Its presence or absence is recorded
3
Description
shivering
Timepoint
recovery
Method of measurement
Its presence or absence is recorded
Intervention groups
1
Description
Control group (41 patients) received 100 milliliter of normal saline as placebo on 20 minutes before surgery and 20 minutes prior to the end of the surgery.
Category
Placebo
2
Description
Preemptive group (21 patients) received 15 milligram/ kilogram of acetaminophen in 100 milliliter normal saline 20 minutes before surgery and 100 milliliter normal saline 20 minutes before the operation ending
Category
Treatment - Drugs
3
Description
Preventive group (21 patients) received 100 milliliter normal saline intravenously 20 minutes before surgery and 15 milligram/ kilogram acetaminophen in 100 milliliter normal saline 20 minutes before end of surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Jalil Makarem, MD
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Jalil Makarem, MD
Street address
Poor sina street, 16th Azar street, Enqelab squre
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?