The objective of this randomized, double-blind clinical trial is to compare the morphine sulfate and intravenous acetaminophen in pain management of patients with surgical acute abdomen who were admitted to emergency department of Fatemi Hospital of Ardabil. 120 patients with acute abdomen will be assigned into the study randomly. Inclusion criteria of the study are Patients above 18 years; stable vital signs; acute abdominal pain; colicky pain in nature. Exclusion criteria of the study are Patients with a history of hypersensitivity to morphine or other opioids; proven or probable pregnancy; breastfeeding; any drug addiction and get an analgesic drugs since six hours before referring to the emergency department. Demographic data, pain severity in admission to the emergency department and 30 minutes after injection, vital signs in admission, side effects, and clinical findings will recorded questionnaires. The pain level, tenderness and the rebound tenderness of the patients will determined by the Visual Analog scale. The subjects will be divided into two groups A and B randomly. The intravenous acetaminophen (15 mg/kg/100cc normal saline in the form of intravenous infusion for 30 minutes) will be administered for group (A) and intravenous morphine sulfate (0.1 mg/kg Slow-acting intravenous injection for 1.5 to 2 minutes) will be administered for group (B). After 30 minutes, the patient's pain is re-examined. Changes in the patient's pain, tenderness, rebound tenderness and side effects will documented in two groups and they will compared. Finally, the collected data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017110427097N5
Registration date:2017-11-17, 1396/08/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-17, 1396/08/26
Registrant information
Name
ِDr Faramarz Darghahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 2000
Email address
mj.naghizadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ardabil University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous Acetaminophen and Morphine sulfate for abdominal pain management in patients with acute abdomen
Public title
Effect of intravenous Acetaminophen for abdominal pain management in patients with acute abdomen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients above 18 years; stable vital signs; acute abdominal pain.
Exclusion criteria: Patients with a history of hypersensitivity to morphine or other opioids; proven or probable pregnancy; breastfeeding; drug addiction; get an analgesic drugs since six hours before admission to the emergency department.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethics committee of Ardebil University of Medical Sciences
Street address
Ardebil University of Medical Sciences, daneshghah ave, Ardebil, Iran
City
Ardebil
Postal code
Approval date
2017-08-27, 1396/06/05
Ethics committee reference number
IR.ARUMS.REC.1396.87
Health conditions studied
1
Description of health condition studied
Acute abdomen
ICD-10 code
R10.0
ICD-10 code description
Acute abdomen
Primary outcomes
1
Description
Pain control
Timepoint
Before the intervention, 30 minuts after the intervention
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Side Effects
Timepoint
Before the intervention, 30 minuts after the intervention
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group (1): Acetaminophen, 15 mg/kg/100cc normal saline, intravenous infusion, for 30 minutes
Category
Treatment - Drugs
2
Description
Intervention group (2): morphine sulfate, 0.1 mg/kg, intravenous injection, for 1.5 to 2 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi Hospital
Full name of responsible person
Mohammad Mosanen Tabatabaii
Street address
Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Ardebil University of Medical Sciences
Full name of responsible person
Dr Shahram Habibzadeh
Street address
Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran
City
Ardebil
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 of Ardebil 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
Ardebil University of Medical Sciences
Full name of responsible person
Mohammad Mosanen Tabatabaii
Position
Medical student
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran
City
Ardebil
Postal code
Phone
+45 33 51 20 06
Fax
Email
Tabatabaii_MM70@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Dr Jafar Ghobadi
Position
Surgeon
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran
City
Ardebil
Postal code
Phone
+98 45 3351 2006
Fax
Email
J.ghobadi@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Mohammad Mosanen Tabatabaii
Position
Medical student
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran
City
Ardebil
Postal code
Phone
+98 45 3351 2006
Fax
Email
Tabatabaii_MM70@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)