(1) Objectives: The aim of this study is to compare the analgesic effects of intravenous acetaminophen with intravenous meperidine after outpatient urologic procedures.
(2) Design: Interventional, randomized, double blind, without placebo, uni central
(3) Setting and conduct: 100 patients 18-69 years old (50 in the meperidine group and 50 in the acetaminophen group) who were candidate for urology outpatient surgery were enrolled in a randomized double blind prospective study.
(4) Participants: Inclusion criteria were patients with physical status ASA I or II; undergoing outpatient urologic procedures (hydrocele, hernia, varicocele); by general anesthesia. The exclusion criteria were patients with history of digestive disorders (nausea, vomiting, gastric ulcer); dizziness; liver disorders.
(5) Intervention: In Group I, before the reverse of general anesthesia, intravenous acetaminophen 1 g was infused within 15 minutes and in Group II, meperidine 0.5 mg per kg was injected bolus intravenously.
(6) Main outcome measures: Post operation pain were evaluated using the visual analog scale (VAS) up to 6 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206094005N5
Registration date:2013-06-08, 1392/03/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-08, 1392/03/18
Registrant information
Name
Khosro Kolahdouzan
Name of organization / entity
Faculty of Paramedical Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 4777
Email address
kolahdozank@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the analgesic effects of intravenous acetaminophen with intravenous meperidine after outpatient urologic procedures
Public title
Comparing the analgesic effects of intravenous acetaminophen with intravenous meperidine after outpatient urologic procedures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with physical status ASA I or II; undergoing outpatient urologic procedures (hydrocele, hernia, varicocele); by general anesthesia
Exclusion criteria: patients with history of digestive disorders (nausea, vomiting, gastric ulcer); dizziness; liver disorders
Age
From 18 years old to 69 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street, Azadi avenue
City
Tabriz
Postal code
Approval date
2013-05-04, 1392/02/14
Ethics committee reference number
9211
Health conditions studied
1
Description of health condition studied
Postoperative pain
ICD-10 code
T88.8
ICD-10 code description
Other specified complications of surgical and medical care, not elsewhere classified
Primary outcomes
1
Description
pain
Timepoint
every hour for 6 hours after operation
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
At the end of operation, infusion of 1 gr intravenous acetaminophen within 15 minutes
Category
Treatment - Drugs
2
Description
At the end of operation,intravenous bolus injection of meperidine 0.5 mg/kg