The comparison between administration of morphine and paracetamol before surgery and paracetamol after surgery for pain management in patients with septorhinoplasty
One the most common complaints after the septorhinoplasty surgery is the post-operative pain which can be irritable and have irreversible complications if it is not managed and controlled properly.
In this study, we aim to assess the effect of morphine and paracetamol, administered intravenously, before and after the operation, on alleviating the post-operation pain in septorhinoplasty surgery.
120 patients with ages 15-60 years who are candidates for septorhinoplasty surgery will be chosen and will be divided randomly into 3 groups with 40 cases.
For the first group, 1 gram paracetamol will be infused intravenously, in 30 minutes, 2 hours before the indication of anesthesia in operation. The second one will be received 1 gram paracetamol which will be infused intravenously in 30 minutes, after the operation in recovery room and the third one will be received 3 mg morphine after the operation in recovery room. After transferring the patients to the ward, every 2 hours, the severity of their pain will be examined by its ranking on the basis of the pain chart which is previously introduced to the patients.
At the end, the efficacy of two drugs and their administration before and after the surgery will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010615102N2
Registration date:2014-02-11, 1392/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-11, 1392/11/22
Registrant information
Name
Soheil Ashkani-Esfahani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 2033
Email address
ashkanis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between administration of morphine and paracetamol before surgery and paracetamol after surgery for pain management in patients with septorhinoplasty
Public title
The comparison between administration of morphine and paracetamol for pain management in nose surgery
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria:patients who have septorhinoplasty surgery from February 2012 till March 2013; patients with 15-60 years-old; 24 hours admission at ENT ward after surgery; filling out the consent form for the trial. exclusion criteria: any history of psychiatric problem such as migraine, depression and psychosis;any history of drug abuse such as morphine and acetaminophen codeine; any complications during or after surgery such as hypoxia, hypercarbia and heart attack and arrest ; any complications after surgery such as infection, fever, bleeding from the site of surgery and inflammation symptoms; lack of patients' compliance during the trial; patients' will to leave the trial.
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
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 Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St
City
Shiraz
Postal code
Approval date
2012-01-21, 1390/11/01
Ethics committee reference number
CT-P-92-3289
Health conditions studied
1
Description of health condition studied
pain management in septorhinoplasty
ICD-10 code
R52.0
ICD-10 code description
Acute Pain
Primary outcomes
1
Description
pain
Timepoint
every 2 hour during the first 24 hours after surgey
Method of measurement
Asking the patient: based on the scale of 0-10 that was told to the patient before surgery
2
Description
the prescribed morphine within 24 hours after surgery
Timepoint
every 2 hour during the first 24 hours after surgey
Method of measurement
scale (Weighing the patient)
3
Description
nause and vomitting after surgery
Timepoint
every 2 hour during the first 24 hours after surgey
Method of measurement
Asking the patient: Presence or Absence
4
Description
apnea
Timepoint
every 2 hour during the first 24 hours after surgey
Method of measurement
Examing the patient: Presence or Absence
Secondary outcomes
empty
Intervention groups
1
Description
group 1: patients who receive 1 gr of paracetamol IV in 30 minutes, 2 hours before induction of anesthesia.
Category
Treatment - Drugs
2
Description
group2: patients who receive 1 gr of paracetamol IV in 30 minutes after surgery and in recovery.
Category
Treatment - Drugs
3
Description
group3: patients who receive 3 mg morphine IV in 1 min, after surgery and in recovery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Shahryar Omidvari
Street address
Khalili Hospital, Khalili St
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masom Masompour
Street address
Shiraz University of Medical Sciences, Zand St
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Shahryar Omidvari
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Fahighi hospital, Zand St
City
Shiraz
Postal code
Phone
+98 71 1626 2033
Fax
Email
omidvarish@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shojaolhagh Taregh
Position
Anesthsiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi hospital, Zand St
City
Shiraz
Postal code
Phone
+98 71 1626 2033
Fax
Email
shtaregh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shahryar Omidvari
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesioloy Department, Shahid Faghihi Hospital, Zand St
City
Shiraz
Postal code
Phone
+98 71 1626 2033
Fax
Email
omidvarish@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)