Evaluating the effect of intravenous Paracetamol or Diclofenac Sodium suppositories on the need for intravenous narcotic administration for pain relief in patients underwent gastrectomy
Patients undergoing gastrectomy do experience sever pain after surgery. The study sample size included 88 patients (age range 40-70 years) with gastric cancer and no history of long-term use of opioids. The study will investigate the effect of adding two analgesic adjuvants for severe pain, including intravenous paracetamol and diclofenac sodium suppositories on pain management of patients with narcotic based therapy as Patient Controlled Analgesia (PCA). The main evaluation criteria include reduction in required dose of narcotics and pain intensity, and patient’s satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112078322N1
Registration date:2012-06-02, 1391/03/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-06-02, 1391/03/13
Registrant information
Name
Alireza Bameshki
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1802 2677
Email address
bameshkiar@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2012-06-04, 1391/03/15
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of intravenous Paracetamol or Diclofenac Sodium suppositories on the need for intravenous narcotic administration for pain relief in patients underwent gastrectomy
Public title
Evaluating the effect of intravenous Paracetamol or Diclofenac Sodium suppositories on the need for intravenous narcotic administration for pain relief in patients underwent stomach surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patients with gastric cancer who are candidate for gastrectomy
2. Age range between 40 to70 years
3. Ability to understand PCA pump use
Exclusion criteria:
1. History of allergy to morphine, acetaminophen, and diclofenac sodium
2. History of heart failure (EF<40%), kidney failure (C2>2), moderate to severe COPD
3. Weight over 10 kilograms or less than 50 kilograms
4. Long-term use of opioids before surgery (for more than 2 weeks continuously)
Age
From 40 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ghoreyshi Building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2012-02-18, 1390/11/29
Ethics committee reference number
900184
Health conditions studied
1
Description of health condition studied
Gastric surgery
ICD-10 code
Z90.3
ICD-10 code description
Acquired absence of part of stomach
Primary outcomes
1
Description
Pain intensity
Timepoint
Within the first 24 hours after intervention
Method of measurement
Verbal Analogue Scale
Secondary outcomes
1
Description
Level of Consciousness
Timepoint
Within the first 24 hours after intervention
Method of measurement
Richmond Agitation Sedation Scale (RASS)
2
Description
Oxygen saturation levels
Timepoint
Within the first 24 hours after intervention
Method of measurement
Pulse oximetry
3
Description
Respiratory rate
Timepoint
Within the first 24 hours after intervention
Method of measurement
Counting the number of breaths per minute
4
Description
Nausea
Timepoint
Within the first 24 hours after intervention
Method of measurement
Times of nausea and womiting
5
Description
Morphine consumption
Timepoint
Within the first 24 hours after intervention
Method of measurement
mg/day
Intervention groups
1
Description
Adding intravenous Paracetamol to Morphine PCA in MP group
Category
Treatment - Drugs
2
Description
Adding Diclofenac Sodium suppositories to Morphine PCA in MD group
Category
Treatment - Drugs
3
Description
Only Morphine PCA to control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgical Oncology Research Center
Full name of responsible person
Dr. Alireza Bameshki
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Ghoreyshi Building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Alireza Bameshki
Position
Associate Professor
Other areas of specialty/work
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Postal code
9137913316
Phone
+98 51 1802 2677
Fax
Email
bameshkiar@mums.ac.ir; surg.rc@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Alireza Bameshki
Position
Associate Professor
Other areas of specialty/work
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Postal code
9137913316
Phone
+98 51 1802 2677
Fax
Email
bameshkiar@mums.ac.ir; surg.rc@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Alireza Bameshki
Position
Associate Professor
Other areas of specialty/work
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Postal code
9133913716
Phone
+98 51 1802 2677
Fax
Email
bameshkiar@mums.ac.ir; surg.rc@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)