Comparison of the effect of Acetaminophen, Pethidine and Ibuprofen on pain relief in patients with acute cholecystitis: a triple blind randomized clinical trial
Objectives: To compare the effect of Acetaminophen, Pethidine and Ibuprofen on pain relief in patients with acute cholecystitis.
Design: A triple blind randomized clinical trial.
Setting and conduct: The eligible patients with acute cholecystitis who will refer to Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 55 years; acute cholecystitis.
Exclusion criteria: Pregnancy; using analgesic within pass 6 hours; addiction to narcotic or psychedelic; contraindication of Acetaminophen, Pethidine, or Ibuprofen; chronic renal failure.
Intervention group 1: Intravenous infusion of 10 mg/kg Acetaminophen in 100 ml normal saline within 30 minutes single dose.
Intervention group 2: Intravenous infusion of 10 mg/kg Ibuprofen in 100 ml normal saline within 30 minutes single dose.
Intervention group 3: Intravenous infusion of 1 mg/kg Pethidine in 100 ml normal saline within 30 minutes single dose.
Primary outcome: Measuring severity of pain before infusion and 30, 60, and 90 minutes after infusion using Visual Analog Scale (VAS).
Secondary outcome: Assessing nausea and vomiting before infusion and 30, 60, and 90 minutes after infusion by taking history.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710059014N191
Registration date:2017-10-05, 1396/07/13
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-10-05, 1396/07/13
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Acetaminophen, Pethidine and Ibuprofen on pain relief in patients with acute cholecystitis: a triple blind randomized clinical trial
Public title
Comparison of the effect of Acetaminophen, Pethidine and Ibuprofen on pain relief in patients with acute cholecystitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 55 years; acute cholecystitis.
Exclusion criteria: Pregnancy; using analgesic within pass 6 hours; addiction to narcotic or psychedelic; contraindication of Acetaminophen, Pethidine, or Ibuprofen; chronic renal failure.
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2017-09-02, 1396/06/11
Ethics committee reference number
IR.UMSHA.REC.1396.409
Health conditions studied
1
Description of health condition studied
Acute cholecystitis
ICD-10 code
K81.0
ICD-10 code description
Acute cholecystitis
Primary outcomes
1
Description
Measuring severity of pain
Timepoint
before infusion and 30, 60, and 90 minutes after infusion
Method of measurement
using Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Assessing nausea and vomiting
Timepoint
before infusion and 30, 60, and 90 minutes after infusion
Method of measurement
by taking history
Intervention groups
1
Description
Intervention group 1: Intravenous infusion of 10 mg/kg Acetaminophen in 100 ml normal saline within 30 minutes single dose.
Category
Treatment - Drugs
2
Description
Intervention group 2: Intravenous infusion of 10 mg/kg Ibuprofen in 100 ml normal saline within 30 minutes single dose.
Category
Treatment - Drugs
3
Description
Intervention group 3: Intravenous infusion of 1 mg/kg Pethidine in 100 ml normal saline within 30 minutes single dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Mohammad Jafari Azandaryani
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 and Technology, Hamadan 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
Besat Hospital
Full name of responsible person
Dr Rasool Salimi
Position
Specialist of Emergency Medicine
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
rasoulsl@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Rasool Salimi
Position
Specialist of Emergency Medicine
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
rasoulsl@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)