Comparison of preemptive analgesia with intravenous administration
of Apotel (paracetamol) & ketorolac on post operative pain relief following elective lower abdominal surgery
Objectives: To compare the preemptive analgesia with intravenous administration of Apotel (paracetamol) & ketorolac on post-operative pain relief following elective lower abdominal surgery.
Research Design: Conduction of a randomized, double-blind, clinical trial, method of randomization: simple randomization by computer.
Major Inclusion Criteria; ASA I-II; patients undergoing elective lower abdomen surgeries.
Major Exclusion Criteria; Opium addicted patients; drug allergy history; a history of gastrointestinal bleeding or kidney failure, lack of consent to participate in this study.Sample Size: 320 patients found eligible based on the inclusion criteria.Interventions: 320 patients in the both groups received either Paracetamol 15 mg / kg IV or Ketorolac 0.4 –o.6 mg / kg IV before the induction of anesthesia. The postoperative pain was evaluated by VAS index at 12,6,2,0 and 24 hours after surgery. In the recovery room (meperidine mg / kg 5/0 - 25/0) is used for analgesia. Finally, nausea and vomiting, shivering by (BSAS) Bedside Shivering Assessment Scale , the amount of drug consumption, intraoperative bleeding and the cost of hospitalization between the two groups were measured and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081723663N1
Registration date:2016-02-04, 1394/11/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-04, 1394/11/15
Registrant information
Name
Mehdi Feiz Dolatabadi
Name of organization / entity
Bandarabbas University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 5009
Email address
feizi_mehdi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research,Bandar Abbas University of Medical Sciences
Expected recruitment start date
2016-01-24, 1394/11/04
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of preemptive analgesia with intravenous administration
of Apotel (paracetamol) & ketorolac on post operative pain relief following elective lower abdominal surgery
Public title
Comparison of Apotel (paracetamol) & ketorolac on post operative pain relief following elective lower abdominal surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria;
ASA I-II; patients undergoing elective lower abdomen surgeries.
Exclusion Criteria;
Opium addicted patients; drug allergy history; a history of gastrointestinal bleeding or kidney failure; lack of consent to participate in this study
Age
From 9 years old to 86 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
320
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
Ethic Committee of Bandar Abbas University Of Medical Sciences
Street address
Shahid Mohamadi Hospital, Jomhori Eslami Blv
City
Bandar Abbas
Postal code
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
HEC-93-1-24-2
Health conditions studied
1
Description of health condition studied
lower abdomen surgeries
ICD-10 code
R10.3
ICD-10 code description
Pain localized to other parts of lower abdomen
Primary outcomes
1
Description
postoperative pain
Timepoint
At 0 ,2,6,24 hours after surgery
Method of measurement
(VAS) Visual Analogue Scale
2
Description
postoperative pain
Timepoint
At 0,6,12,24 hours after surgery
Method of measurement
(BSAS) Bedside Shivering Assessment Scale
Secondary outcomes
empty
Intervention groups
1
Description
Ketorolac 0.4 –o.6 mg / kg IV is administered for the first group before the induction of anesthesia.
Category
Treatment - Drugs
2
Description
Paracetamol 15 mg / kg IV is administered for the second group before induction of anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohamadi Hospital
Full name of responsible person
Hashem Jarineshin
Street address
Shahid Mohamadi Hospital, Jomhori Eslami Blvd.
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Bandar Abbas University of Medical Sc
Full name of responsible person
Dr Abdolazim Nejati Zadeh
Street address
Vice Chancellor for Research , Shahid Mohammadi Hospital, Jomhori Eslami BLV.
City
Bandar Abbas
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, Bandar Abbas University of Medical Sc