Determining the effectiveness and side effects of intravenous ibuprofen and intravenous ketorolac in postoperative laparoscopic cholecystectomy pain control
Design
This study is a triple blind, controlled clinical trial with parallel groups
Settings and conduct
This was a randomized, triple-blind placebo-controlled trial at Imam Khomeini hospital in Ardebil. A total of 90 patients aged 20-60 years, undergoing laparoscopic cholecystectomy were randomized
to receive either postoperative 800 mg IV-ibuprofen or 30 mg IV-Ketorolac or placebo (normal saline). Postoperative pain was managed with intravenous fentanyl (0.5 µ/Kg ) as IV-PCA .
Participants/Inclusion and exclusion criteria
Study inclusion criteria: Patients undergoing laparoscopic cholecystectomy surgery at Imam Khomeini Hospital in Ardebil; At the age of 20-60 years; Consent to participate in research.
Non inclusion criteria: All patients who have certain conditions, such as pregnancy and heart disease or kidney disease, etc., are excluded.
Intervention groups
Intervention Group 1: receive intravenous ibuprofen 800 mg.
Control Group: receive placebo.
Intervention Group 2: receive Intravenous ketorolac 30mg.
All three groups receive medication at 0, 8, and 16 hours after surgery.
Main outcome variables
Abdominal pain; satisfaction of analgesia;, nausea and vomiting; shoulder pain; the using of opioids.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171003036530N2
Registration date:2018-09-03, 1397/06/12
Registration timing:retrospective
Last update:2018-09-03, 1397/06/12
Update count:0
Registration date
2018-09-03, 1397/06/12
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3358 2779
Email address
s.hoghughi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of efficacy and side effects of IV( intravenous) Ibuprofen and intravenous Ketorolac in laparoscopic cholecystectomy patients.
Public title
Comparison the effect of IV Ibuprofen and IV Ketorolac on post operation pain.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are undergoing laparoscopic cholecystectomy surgery at Imam Khomeini Hospital in Ardebil.
Being at the age of 20 and 60 years old
Patients who accept to participate in the research.
Exclusion criteria:
Pregnancy
History of Asthma and Pulmunary disease
History of heart disease
History of CKD (chronic kidney disease) or dialysis
History of GI (Gastrointestinal) bleeding
History of HTN (hypertension)
History of Anemia
Using Warfarin
Consumers simultaneously ACEI (angiotensin converting enzyme inhibitor) and Furosemide
Drug dependence
Allergic reaction to ibuprofen or NSAIDS or celecoxib
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is permuted block randomization in the individual unit. There are 90 sealed envelopes containing three types of code for example there are 30 code numbers for ibuprofen. The person in the operating room will pick an envelope for each patient without knowing the content and the drug will be administered by another person who is not aware of the drug's type.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The randomized order of interventions was concealed in opaque individual envelopes by the staff nurse, which were later opened by the nurse in recovery room at the end of surgery. The nurse prescribed drugs(ketorolac, ibuprofen or placebo in equal volume in similar syringes) without knowing patient's ID. The patient's data was collected every six hours without knowing the type of drugs. The principal investigator, patients and outcome assessmentor were blinded to group status, knowing only randomization group codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardebil University of Medical Sciences
Street address
Daneshgah Ave
City
Ardebil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2017-10-02, 1396/07/10
Ethics committee reference number
IR.ARUMS.REC.1396.136
Health conditions studied
1
Description of health condition studied
cholecystitis
ICD-10 code
k80
ICD-10 code description
cholecystitis
Primary outcomes
1
Description
abdominal pain
Timepoint
6,12 ,18, 24 hours after the operation, pain will be evaluated.
Method of measurement
The assessment of abdominal pain is based on the Visual Analogue Scale system.
2
Description
shoulder pain
Timepoint
6,12,18,24 hours after surgery
Method of measurement
The assessment of pain is based on the Visual Analogue Scale system.
3
Description
Nausea and Vomiting
Timepoint
6,12,18,24 hours after surgery
Method of measurement
The assessment is based on the N/V(Nausea and Vomiting)system.
4
Description
Loss of consciousness
Timepoint
6,12,18,24 hours after surgery
Method of measurement
The assessment is based on the Ramsay score.
Secondary outcomes
empty
Intervention groups
1
Description
The first Intervention group will receive a pain pump containing Fentanyl 100 ml and then intravenous Ketorolac 30 mg at intervals of zero, 8 and 16 hours after surgery.
Category
Other
2
Description
The second Intervention group will receive a pain pump containing Fentanyl and then intravenous Ibuprofen 80 mg at intervals of zero, 8 and 16 hours after surgery.
Category
Other
3
Description
Control group will receive a pain pump containing fentanyl and then intravenous Placebo at intervals of zero, 8 and 16 hours after surgery.