Randomized clinical trial comparing intravenous Acetaminophen with Morphine on pain and peritoneal irritation signs in patients with acute surgical abdomen
(1) Objectives: Our aim in this study is to compare intravenous Acetaminophen with morphine on pain and peritoneal irritation signs in patients with acute surgical abdomen. (2) Design: In a double blinded study, one hundred and twenty patients from both genders referring to emergency department, Imam Reza Hospital, Tabriz with abdominal pain will be studied. Patients are diagnosed with acute surgical abdomen and are going to be transported to operation room. They will be included in the clinical trial after qualifying the inclusion and exclusion criteria and obtaining the informed consent. (3) Setting and conduct: One hundred and twenty patients will be randomized into two groups of 60. Participants will be chosen from patients with acute surgical abdomen. Inclusion criteria are patients diagnosed with acute surgical abdomen; age between 12 and 70 years old. Exclusion criteria are patients with a history of drug addiction; patients with a history of narcotic or sedative injection in the last week. (4) Intervention: Just before surgery morphine will be administered for one groups with a 0.1 mg/kg and for the other group intravenous acetaminophen will be administered with a dose of 15 mg/kg. (5) Main outcome measures: Patient's pain, tenderness and rebound tenderness will be evaluated based on visual analog scale before injection. Thirty minutes after the injection, patient's pain will be examined and evaluated again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052311067N2
Registration date:2013-07-20, 1392/04/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-20, 1392/04/29
Registrant information
Name
Mahboub Pouraghaei
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 2078
Email address
pouraghaeim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized clinical trial comparing intravenous Acetaminophen with Morphine on pain and peritoneal irritation signs in patients with acute surgical abdomen
Public title
Comparison of injection form of acetaminophen with morphine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients diagnosed with acute surgical abdomen; age between 12 and 70 years old.
Exclusion criteria: Patients with a history of drug addiction; patients with a history of narcotic or sedative injection in the last week.
Age
From 12 years old to 70 years old
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
For randomizing patients into two groups, we used pocket method. Numbers from 1 to 120 were put in some pockets which were similar in size and color and were shuffled. While including a patient in the study one pocket was chosen randomly. If the figure was in range of 1 to 60, patient was placed in acetaminophen group and if it was in range of 61 to 120 patient was placed in morphine group. We used a double blinded study to prevent research outcomes from being influenced by the placebo effect or observer bias. In this study, neither the emergency physician nor the patient knew about the administered drug (morphine or acetaminophen)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Ethics committee، Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Postal code
Approval date
2012-03-26, 1391/01/07
Ethics committee reference number
91170
Health conditions studied
1
Description of health condition studied
Abdominal pain and tenderness
ICD-10 code
R10.0
ICD-10 code description
Severe abdominal pain (generalized)(localized)(with abdominal rigidity)
Primary outcomes
1
Description
Patient's pain
Timepoint
Before injection, 30 minutes after injection
Method of measurement
Visual analogue scale
2
Description
Patient's abdominal tenderness
Timepoint
Before injection, 30 minutes after injection
Method of measurement
Physical exam and clinical evaluation
3
Description
Patient's abdominal rebound tenderness
Timepoint
Before injection, 30 minutes after injection
Method of measurement
Physical exam and clinical evaluation
Secondary outcomes
empty
Intervention groups
1
Description
In acetaminophen group, one shot of intravenous acetaminophen (trade name: Apotel) will be injected with a dose of 15 mg/kg intravenously.
Category
Treatment - Drugs
2
Description
In morphine group, one shot of morphine (trade name: MS) will be injected with a dose of 0.1 mg/kg intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Peyman Emamverdizadeh
Street address
Department of Emergency Medicine, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square, Tabriz
City
Tabriz
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, Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Emergency Medicine, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahboub Pouraghaei
Position
Assistant Professor/ Specialist in Emergency Medicine
Other areas of specialty/work
Street address
Department of Emergency Medicine, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
Email
pouraghaeim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Emergency Medicine resident
Full name of responsible person
Dr. Peyman Emamverdizadeh
Position
Tabriz University of Medical Sciences
Other areas of specialty/work
Street address
Department of Emergency Medicine, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)