(1) Objectives: The aim of this paper was to measure the analgesic effect of intravenous ketorolac during the immediate postoperative period in recovery room for postoperative pain relief as well as their side effects in patients undergoing mandibular fracture surgery to assess the analgesic effect and the need for opioids. (2) Design: This is a double-blind randomised clinical trial study, that severity of pain was evaluated by visual analoug scale and the amount of opioid consumption after surgery. (3) Setting and conduct: A total of 50 adult patients were selected for this randomized controlled trial. All subjects were divided into two groups to receive ketoroloc or placebo. The anesthesiologist administered 30 mg of ketoroloc intravenously end of the operation in post anesthesia care uint immediately upon the onset of pain in study group and in the control group patients received placebo with 1cc of distilled water solution. (4) Participants including major eligibility criteria: Subjects who had systemic disease and history of drug consumption and lack of signed informed consent will be excluded from the study sample. (5) Intervention: Patients in the study group will be received an intravenous "Ketoroloc" 30 mg bolus for 30 sec end of the operation in post anesthesia care uint immediately upon the onset of pain and the placebo group will receive " Distilled Water " as same bolus volume in a 30-sec intravenous infusion. (6) main outcome measures: After surgery the patients were monitored for up to 4 hours in the recovery room and pain intensity (VAS 100-mm) is measured by a person who was uninformed about case and control groups every 5 min. Post-operative complications will be asked in the questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607271674N13
Registration date:2016-08-06, 1395/05/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-06, 1395/05/16
Registrant information
Name
Hamid Reza Eftekharian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3636 4001
Email address
eftekharhr@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Supported by Vice-Chancellery of Research and Technology, Shiraz University Of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2016-04-22, 1395/02/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous ketorolac on postoperative pain in mandibular fracture surgery
Public title
Treatment of postoperative pain with intravenous ketorolac in mandibular fracture surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included 16-47 year old patients whom were scheduled to undergo mandibular fractured surgy; Subjects who had systemic disease and history of drug consumption; history of drug allergic reaction; hepatic and renal dysfunction and lack of signed informed consent will be excluded from the study sample
Age
From 16 years old to 47 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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 Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Vice-Chancellery of Research and Technology, Zand Avenue, Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
IR.SUMS.REC.1394.55
Health conditions studied
1
Description of health condition studied
Acute pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Intensity of postoperative pain
Timepoint
Immediately after surgery to 4 hours after surgery each 5 min.
Method of measurement
VAS
2
Description
Use of narcotic (Pethedin) after surgery for postop. pain management
Timepoint
To 4 hours after surgery
Method of measurement
Nursing reports
Secondary outcomes
1
Description
post-operative complications of Ketoroloc
Timepoint
Immediately after surgery to 4 hours after surgery
Method of measurement
Nursing reports
Intervention groups
1
Description
Patients in the interventional group (first group) will be received an intravenous "Ketoroloc" 30 mg for 30 Sec. end of the operation in post anesthesia care uint immediately upon the onset of pain
Category
Treatment - Drugs
2
Description
Patients in the the second group will receive " placebo" as same bolus volume of " Distilled Water " in a 30-Sec. intravenous infusion end of the operation in post anesthesia care uint immediately upon the onset of pain
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Rajaei Hospital
Full name of responsible person
Hamid Reza Eftekharian
Street address
Shiraz University Of Medical Sciences, Shiraz Rajaei Hospital, Chamran Blvd., Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology, Shiraz University Of Medical Sciences
Full name of responsible person
Sayed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Vice-Chancellery of Research and Technology, Zand Avenue, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology, 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
School of Dentistry, Shiraz University of Medical sciences
Full name of responsible person
Hamid Reza Eftekharian
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz University Of Medical Sciences, Shiraz Rajaei Hospital, Chamran Blvd., Shiraz
City
Shiraz
Postal code
Phone
+98 71 3648 3783
Fax
Email
eftekharhr@sums.ac.ir
Web page address
www.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry, Shiraz University of Medical sciences
Full name of responsible person
Hamid Reza Eftekharian
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz University Of Medical Sciences, Shiraz Rajaei Hospital, Chamran Blvd., Shiraz
City
Shiraz
Postal code
Phone
+98 71 3648 3783
Fax
Email
eftekharhr@sums.ac.ir
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry, Shiraz University of Medical sciences
Full name of responsible person
Hamid Reza Eftekharian
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz University Of Medical Sciences, Shiraz Rajaei Hospital, Chamran Blvd., Shiraz
City
Shiraz
Postal code
Phone
+98 71 3648 3783
Fax
Email
eftekharhr@sums.ac.ir
Web page address
www.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)