Protocol summary
-
Study aim
-
To compare the effect of Acetaminophen, Pethidine and Ibuprofen on pain relief in patients with acute cholecystitis.
-
Design
-
A triple blind randomized clinical trial.
-
Settings and conduct
-
The eligible patients with acute cholecystitis who will refer to Besat Hospital during the study period will be enrolled into the trial.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Age of 18 to 75 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 groups
-
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.
-
Main outcome variables
-
Primary outcome: Measuring the severity of pain
Secondary outcome: Assessing nausea and vomiting
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT201710059014N191
Registration date:
2017-10-05, 1396/07/13
Registration timing:
prospective
Last update:
2019-03-07, 1397/12/16
Update count:
1
-
Registration date
-
2017-10-05, 1396/07/13
-
Registrant information
-
-
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 75 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 75 years old
-
Gender
-
Both
-
Phase
-
2
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
90
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
-
Blinding (investigator's opinion)
-
Triple blinded
-
Blinding description
-
The shape of the medications will be perfectly the same. Therefore, 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
-
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.
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
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
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available