We designed this prospective, double-blind randomized study to compare the analgesic efficacy of a single- dose of rectal Indomethacine with a single- dose of IV Paracetamol, and those who only receive local infiltration of Lidocaine +Epinephrine in patients undergoing septorhinoplasty.
Methods: 75 patients with ASA class I and II undergoing open septorhinoplasty are randomized to 3 groups: group 1 receives 1 gr paracetamol IV in 100 ml normal saline, group 2 rectal indomethacine 100 mg, and group 3 normal saline 100 ml infusion 20 minutes before the end of surgery. A standard anesthetic method is used and all patients receive local infiltration of lidocaine + epinephrine in the operating sites. Postoperative pain is assessed by a visual analogue scale score at 15 and 30 min and at 1, 2, 3, 4, 5, 6 ,7, and 8 hours after surgery. IV Morphine boluses is used for supplementary analgesia. Sedation scores and the need for supplementary analgesia and adverse events during the first 8 h after surgery are also recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041815322N2
Registration date:2015-04-20, 1394/01/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-20, 1394/01/31
Registrant information
Name
Shideh Dabir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2595
Email address
sdabir@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Tracheal Diseases Research Center
Expected recruitment start date
2014-04-28, 1393/02/08
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of intravenous Paracetamol and Indomethacin suppository for pain relief after septorhinoplasty
Public title
The effects of intravenous Paracetamol and Indomethacin suppository for treating pain after septorhinoplasty surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA class 1-2, 18-50 years- old patients
Exclusion criteria: drug or alcohol abuse; allergy to study drugs or their constituents; history of renal or hepatic failure or disease; asthma; peptic ulcer; a history of seizures; history of chronic pain.
Age
From 75 years old to 43 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
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
Islamic Azad University of Pharmaceutical Sciences Branch
Street address
Shariati street, Yakhchal street
City
Tehran
Postal code
Approval date
2014-05-21, 1393/02/31
Ethics committee reference number
2867
Health conditions studied
1
Description of health condition studied
Pain after septorhinoplasty surgery
ICD-10 code
Y83.8
ICD-10 code description
Surgical and other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Postoperative pain scores
Timepoint
15 and 30 min and at 1, 2, 3, 4, 5, 6 ,7, and 8 hours after surgery.
Method of measurement
A o to 10 visual analogue scale (VAS) score
Secondary outcomes
1
Description
Supplementary analgesia
Timepoint
During 8 hours study period
Method of measurement
if pain scores are 4 or greater or on patient's demands.
2
Description
Sedation scores
Timepoint
15 and 30 min , and 1, 2, 3, 4,5,6,7, and 8 hours after surgery.
Method of measurement
Ramsay Sedation Score
3
Description
Adverse effects
Timepoint
Continuously during 8 hours study period.
Method of measurement
Observation
Intervention groups
1
Description
Group 1 receives a single dose of 1 gr Paracetamol IV in 100 ml normal saline, 20 minutes before the end of surgery.
Category
Treatment - Drugs
2
Description
Group 2 receives a single dose of rectal Indomethacin 100 mg, 20 minutes before the end of surgery.
Category
Treatment - Drugs
3
Description
Group 3 receives Normal saline 100 ml infusion, 20 minutes before the end of surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
National Research Institute of Tuberculosis & Lung Diseases, Masih Daneshvari Hospital
Full name of responsible person
Dr. Tahereh Parsa
Street address
Department of Anesthesiology, Masih Daneshvari Hospital, Darabad, Niavaran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tracheal Diseases Research Center, National Research Institute of Tuberculosis & Lung Diseases, Masi
Full name of responsible person
Dr. Roya Farzanegan
Street address
Tracheal Diseases Research Center, Masih Daneshvari Hospital, Darabad, Niavaran
City
Tehran
Grant name
16-11-92
Grant code / Reference number
p/25/29/45095
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tracheal Diseases Research Center, National Research Institute of Tuberculosis & Lung Diseases, Masi
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
Azad University of Pharmaceutical Sciences, College of Pharmacy
Full name of responsible person
Miss Yalda Parviz
Position
Student of Pharmacy Degree, PhD
Other areas of specialty/work
Street address
Shariati street, Yakhchal street
City
Tehran
Postal code
Phone
+98 21226400515
Fax
Email
yali_par@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tracheal Diseases Research Center, National Research Institute of Tuberculosis & Lung Diseases, Masi
Full name of responsible person
Dr. Shideh Dabir
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Department of Anesthesiology, Masih Daneshvari Hospital, Darabad, Niavaran
City
Tehran
Postal code
1956944413
Phone
+98 21 2610 9644
Fax
+98 21 2610 9644
Email
sdabir@sbmu.ac.irshdabir@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
National Research Institute of Tuberculosis & Lung Diseases, Masih Daneshvari Hospital, Shahid Behes
Full name of responsible person
Dr. Tahereh Parsa
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Department of Anesthesiology, Masih Daneshvari Hospital, Darabad, Niavaran
City
Tehran
Postal code
1956944413
Phone
+98 21 2610 9644
Fax
+98 21 2610 9644
Email
tparsa849@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)