Comparison effect of Morphine and Apotel versus Placebo in relieving pain and final diagnosis and complications from appendicitis in patients with suspected acute appendicitis
Target:
The effect of narcotics to patients with suspected acute appendicitis to the final diagnosis and complications from appendicitis.
In a clinical trial, a randomized, double-blind (patient and researchers), Non-pregnant patients over 15 years old come to the emergency room of Rasool Akram Hospital with abdominal pain in RLQ that based on history and physical examination are suspicious of acute appendicitis enrolled in the study. Exclude patients who were transferred from another hospital with a diagnosis of appendicitis or patients who received narcotic before hospital and patient with renal failure or Sensitivity to contrast agent of CT scan and patients with the history of trauma. 180 patients enrolled in the study are classified into the three groups (randomly using a table of random numbers) the following will be:
1) Patients on arrival at the emergency receive Placebo (normal saline) 2) Patients on arrival at the emergency receive intravenous Morphine (0.1 mg / kg) 3) Patients at the time of admission receive Apotel (15 mg / kg)
At the time of admission to the emergency primary information of patients including demographic and clinical and drug history and current clinical features and symptoms of patients can be collected through interviews and physical examination.In all three group pain intensity is determined with The scoring system Visual Analogue Scale (VAS) Then, the above intervention done by the emergency services. The diagnostic process and tools that used and final diagnosis follow and recorded with executive of plan. Patients who need surgery before entering the operating room again pain intensity is determined based on VAS. Determined and recorded the Complications during and after surgery and diagnosis during surgery.The final diagnosis of appendicitis based on pathology will be after surgery. Patients who do not find the need for surgery in the hospital at least 12 hours and up to 48 hours for telephone follow-up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021531324N2
Registration date:2017-05-16, 1396/02/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-16, 1396/02/26
Registrant information
Name
Seyed Hamzeh Mousavie
Name of organization / entity
Iran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 912 296 7445
Email address
mousavie.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor Of Research, ]قشد University of Medical Sciences
Expected recruitment start date
2016-04-29, 1395/02/10
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of Morphine and Apotel versus Placebo in relieving pain and final diagnosis and complications from appendicitis in patients with suspected acute appendicitis
Public title
The effect of relieving pain in patients with suspected acute appendicitis admission to the final diagnosis and complications from appendicitis in patients of Rasoul Akram Hospital
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Non-pregnant patients; over 15 years old; with abdominal pain in the RLQ and based on the initial history and physical examination are suspicious of acute appendicitis.
Exclusion criteria: Patients who were transferred from another hospital with the diagnosis of appendicitis; use relieving pain before they come; patient with renal failur; Sensitivity to contrast agent of CT scans; patients with a history of traum
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University Of Medical Science
Street address
Near Milad tower, Hemmat highway, Tehran
City
Tehran
Postal code
Approval date
2016-04-05, 1395/01/17
Ethics committee reference number
IR.IUMS.REC 1394.9011216147
Health conditions studied
1
Description of health condition studied
acute appendisitis
ICD-10 code
K35, K36,
ICD-10 code description
Diseases of appendix
Primary outcomes
1
Description
abdominal pain
Timepoint
when they come to hospital and before the go to OR
Method of measurement
VAS analog
Secondary outcomes
1
Description
musked symptom with pain relieving
Timepoint
during hospitalizationا
Method of measurement
physical exam
Intervention groups
1
Description
Intervention group: Amp morphine sulfate 0.1 mg/kg in 10 cc normal saline IV slow injects
Category
Diagnosis
2
Description
Intervention group: Amp Apotel 15mg/kg in 100 CC normal saline infusion in 20 min
Category
Diagnosis
3
Description
control group : vial normal saline 2CC IV stat
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Shabnam Tarahomi
Street address
Rasool Akram Hospital, Niayesh street, Satarkhan street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research, Iran University of Medical Sciences
Full name of responsible person
Mrs Irani
Street address
Near Milad tower, Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research, Iran 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
Rasool Akram Hospital
Full name of responsible person
Shabnam Tarahomi
Position
Intern
Other areas of specialty/work
Street address
Plaque 83, Gonabad street, Kokab street, Sattarkhan street
City
Tehran
Postal code
Phone
+98 21 6643 1917
Fax
Email
shabnam.tarahomi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasool Akram Hospital
Full name of responsible person
Shabnam Tarahomi
Position
Intern
Other areas of specialty/work
Street address
Niayesh street, Sattarkhan street
City
Tehran
Postal code
Phone
+98 21665150009
Fax
Email
shabnam.tarahomi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rasool Akram Hospital
Full name of responsible person
Shabnam Tarahomi
Position
Intern
Other areas of specialty/work
Street address
Plaque 83, Gonabad street, Kokab street, Sattarkhan street
City
Tehran
Postal code
Phone
+98 21 6643 1917
Fax
Email
shabnam.tarahomi@yaho.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)