The goal of this study (Phase IV) is to evaluate the effect of Morphine on the diagnostic process of acute abdominal pain. Two hundred patients with acute abdominal pain referring to the emergency department of Imam Reza Hospital, Mashhad, Iran during 2013-2014 are divided into two groups. Any patients with acute abdominal pain will be included in the study. Exclusion criteria are patients less than 18 years, pregnants, patients with the history of abdominal pain more than 3 days, hypotension (blood pressure less than 90 mmHg), traumatic patients, and those with a history of allergy to Morphine and its derivatives. Patients with an even medical record number as the study group and those with an odd medical record number as the control group. Both patients and physicians are blinded to patients’ assignment. The study group will receive 0.1 mg/kg Morphine (IM). If the preoperative time becomes more than 5 hours, the morphine dosage will be repeated with the primary dose. Normal saline in equal volume of Morphine Sulfate 0.1 mg/kg as a placebo is given to the control group. Other diagnostic and treatment procedures are the same in both groups. After two hours, all patients are examined by the same resident of surgery who is blinded to the patient’s assignment. The diagnosis of the resident before and after the intervention will be recorded. After etiologic diagnosis of the pain, the effect of Morphine will be evaluated. The primary outcome measure of the study is the disease diagnosis. There is no secondary outcome to be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092224128N1
Registration date:2015-12-26, 1394/10/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-26, 1394/10/05
Registrant information
Name
Mohammad Yarani
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3222 2300
Email address
mohammad.yarani@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Birjand University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Morphine analgesia on diagnostic accuracy of abdominal pain
Public title
Morphine effects in in patients with abdominal pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Any patient with acute abdominal pain
Exclusion criteria: Patients less than 18 years old; Pregnancy; Patients with the history of abdominal pain more than 3 days; Hypotension (blood pressure less than 90 mmHg); Traumatic patients; Patients with a history of allergy to morphine and its derivatives
Age
From 18 years old to 90 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Using random number table for sampling, patients with an even medical record number were assigned to the study group and those with an odd medical record number were assigned to the control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghaffari Boulvard
City
Birjand
Postal code
Approval date
2014-08-20, 1393/05/29
Ethics committee reference number
931245
Health conditions studied
1
Description of health condition studied
Acute abdomen
ICD-10 code
R10.1, R10
ICD-10 code description
Pain localized to upper abdomen; Epigastric pain; Pelvic and perineal pain; Pain localized to other parts of lower abdomen; Other and unspecified abdominal pain: Abdominal tenderness NOS, Colic: NOS, infantile
Primary outcomes
1
Description
Disease diagnosis
Timepoint
Two hours after intervention
Method of measurement
Physical examination
Secondary outcomes
1
Description
No secondary outcome measure
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Administration of 0.1 mg/kg Morphine Sulfate (Darou Pakhsh, Iran) in the study group
Category
Diagnosis
2
Description
Administration of normal saline in equal volume of Morphine Sulfate 0.1 mg/kg as a placebo in the control group
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Department of Immam Reza Hospital
Full name of responsible person
Mahtab Ghaemi
Street address
Imam Reza Hospital, Ebnesina Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor, Birjand University of Medical Science
Full name of responsible person
Dr Asghar zZarban
Street address
Ghaffari Boulvard
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor, Birjand University of Medical Science
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
Birjand University of Medical Sciences
Full name of responsible person
Mahtab Ghaemi
Position
Scholar
Other areas of specialty/work
Street address
Ghaffari Boulvard
City
Birjand
Postal code
Phone
+98 51 3842 4981
Fax
Email
ghaemim881@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Science
Full name of responsible person
Dr Mohammad Yarani
Position
National Board of Surgery
Other areas of specialty/work
Street address
Birjand, Department of Surgery, Imam Reza Hospital
City
Birjand
Postal code
Phone
+98 56 3222 2300
Fax
Email
mohammadyarani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mahtab Ghaemi
Position
Scholar
Other areas of specialty/work
Street address
Ghaffari Boulvard
City
Birjand
Postal code
Phone
+98 51 3842 4981
Fax
Email
ghaemim881@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)