Comparison of the effect of oral Oxycodone versus intravenous Ketorolac on post laparoscopic cholecystectomy pain
Design
Double blinded randomized clinical trial
Settings and conduct
60 patients referred to Loghman Hospital operating room will be divided into 2 groups: receiving oxycodone or ketorolac. Before induction of anesthesia the former group receive 30 mg of oral oxycodone, while 30 mg ketorolac in 100cc normal saline is administered to the latter intravenously over 30 minutes.Postoperative pain scores are measured and documented based on NRS.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Patients candidate for elective laparoscopic cholecystectomy
Age between 18-65 year
No history of drug abuse
No history of psychologic disease
No history of sensitivity to drugs in study
Exclusion Criteria
Intervention groups
Oxycodone group: In addition to routine analgesics, patients receive oral oxycodone to the control postoperative pain.
Ketorolac group: In addition to routine analgesics, patients receive intravenous ketorolac to the control postoperative pain.
Main outcome variables
Severity of postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181216041991N1
Registration date:2019-01-23, 1397/11/03
Registration timing:registered_while_recruiting
Last update:2019-01-23, 1397/11/03
Update count:0
Registration date
2019-01-23, 1397/11/03
Registrant information
Name
masoud nashibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 4040
Email address
masoudnashibi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral Oxycodone versus intravenous Ketorolac on post laparoscopic cholecystectomy pain
Public title
Comparison of the effect of oral Oxycodone versus intravenous Ketorolac on post laparoscopic cholecystectomy pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for laparoscopic cholecystectomy
Age between 18-65 year
Exclusion criteria:
No history of drug abuse
No history of psychologic disease
No allergy to studied drugs
No pregnancy and lactation
No clinical sign due to sepsis or other inflammatory disease
No history of liver and renal failure
No history of GI bleeding
No history of coagulopathies
No history of sign of neuropathy
No diagnosis of gangrenous cholecystitis
No diagnosis of generalized peritonitis
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed envelop method
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher open the pockets confidentially to learn the patient's group. The patients pain scores and other results are documented by an unaware personnel.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
The effect of medications on post laparoscopic cholecystectomy pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postoperative pain
Timepoint
1,2,4,6,12 hours postoperative
Method of measurement
Numerical rating Scale;The NRS is a 10 cm horizontal bar which is divided to 0-10 pieces. Respondent selects a whole number (0–10 integers) that best reflects the intensity of his/her pain. Number zero eqauals no pain, while number ten means unbearable pain.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group patients receive 30 mg of oral oxycodone before anesthesia induction.
Category
Treatment - Drugs
2
Description
Intervention group: In the second group before anesthesia induction patients receive 30 mg of intravenous ketorolac dissolved in 100 ml normal saline in 30 minute.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
loghman hakim hospital
Full name of responsible person
Masoud nashibi
Street address
South kargar street, kamali street,loghman hakim hospital