Study objective: To assess the effectiveness of Promethazine, Morphine and Diclofenac inter appointment pain reduction in patients after appendectomy surgery
Study design: randomized,triple-blind
Inclusion criteria: Patients with acute appendicitis between 49-15 years, patient consent Exclusion criteria: drug addiction and smoking, previous surgery, hypotension, underlying disease, complicated appendicitis
Study population: patients 49-15 years of hospital emergency appendectomy Sabzevar
sample size: 112 people
Intervention Study:Promethazine intramuscular injection of Morphine, and Diclofenac in the first hour after appendectomy
primary outcome:Pain after appendectomy
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014011416221N1
Registration date:2014-02-15, 1392/11/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-15, 1392/11/26
Registrant information
Name
Ali Tajabadi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1264 7375
Email address
tajabadia@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences Research Council
Expected recruitment start date
2012-04-16, 1391/01/28
Expected recruitment end date
2012-09-18, 1391/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Promethazine efficacy of Morphine and Diclofenac inter appointment pain reduction in patients between 15-49 years after appendectomy surgery
Public title
Effect of Promethazine,Diclofenac and Morphine on pain appendectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with acute appendicitis between 49-15 years; patient consent Exclusion criteria: drug addiction and smoking; previous surgery; hypotension, underlying disease; complicated appendicitis
Age
From 15 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Sabzevar, Khorasan razavi
City
Sabzevar
Postal code
98
Approval date
2012-04-16, 1391/01/28
Ethics committee reference number
391020202
Health conditions studied
1
Description of health condition studied
appendectomy
ICD-10 code
K35
ICD-10 code description
Acute appendicitis
2
Description of health condition studied
appendectomy
ICD-10 code
k36
ICD-10 code description
Other appendicitis
3
Description of health condition studied
appendectomy
ICD-10 code
k37
ICD-10 code description
Unspecified appendicitis
4
Description of health condition studied
appendectomy
ICD-10 code
K38
ICD-10 code description
Other diseases of appendix
Primary outcomes
1
Description
pain of post operation
Timepoint
half and one oclock post of intervention
Method of measurement
visual analouge scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Promethazine 50 mg intramuscularly, IM, once postoperative
Diclofenac 75 mg intramuscularly, IM, once postoperative
Category
Treatment - Drugs
2
Description
Control group:
Morphine, injections of 10 mg intramuscularly, once postoperative
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Training Center - Research - Relief Therapy martyr doctor beheshti
Full name of responsible person
Ali Tajabadi
Street address
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr,Mohammadzadeh
Street address
Sabzevar University of Medical Sciences, Sabzevar, Khorasan razavi
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Ali Tajabadi
Position
Msc
Other areas of specialty/work
Street address
Department of Sabzevar University of Medical Sciences, Tehran Road, Sabzevar
City
Sabzevar
Postal code
98
Phone
+98 57 1444 6070
Fax
Email
Tajabadia@Medsab.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ali Tajabadi
Position
Msc of Nursing
Other areas of specialty/work
Street address
Department of Sabzevar University of Medical Sciences, Sabzevar
City
Sabzevar
Postal code
98
Phone
+98 57 1444 6070
Fax
Email
Tajabadia@Medsab.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ali Tajabadi
Position
Msc
Other areas of specialty/work
Street address
Deprtment of Sabzevar University of Medical Sciences, sabzevar
City
Sabzevar
Postal code
98
Phone
+98 57 1444 6070
Fax
Email
Tajabadia@Medsab.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)