In a double-blind randomized-controlled trial we wanted to assess the efficacy of intravenous acetaminophen in controlling early postoperative pain in maxillofacial inpatient operations compared to routinely administered opioids. We studied 50 consecutive patients. All patients had an operation on their mandible. The patients were randomly divided into two groups by simple randomization. Postoperative pain was measured by visual analogue score (VAS) 1, 2, 4, 8, 12 and 24 hours after the operation. The first group (25 patients) received postoperative pethidine 1 mg per kg every 4 hours while the second group (25 patients) received postoperative acetaminophen 15 mg per kg every 6 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307104731N12
Registration date:2013-07-18, 1392/04/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-18, 1392/04/27
Registrant information
Name
Hamze Hosseinzade
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 7055
Email address
hosseinz@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental and Periodontal Research Center-Tabriz University of Medical Sciences,Tabriz,Iran
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pain releif effect of intravenous acetaminophen and pethidine in maxillofacial surgery
Public title
Pain releif effect of intravenous acetaminophen and pethidine in maxillofacial surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients that need mandibular surgery; having 18-50 years old; without systemic disease; without other organs injury.
exclusion criteria: history of allergy to pethrdine and acetaminophen; alcohol consumers; drug abusers; psycologic disease; Monoaminoaxidase (MAO)inhibitors consumers; history of chronic pain; surgery time over 2 hours.
Age
From 18 years old to 50 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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2013-04-20, 1392/01/31
Ethics committee reference number
928
Health conditions studied
1
Description of health condition studied
Oral and maxillofacial surgery
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Maxillofacial surgeries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain severity
Timepoint
Before and 24 hours after intervention
Method of measurement
Visual Analogue Scale(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
intrvention: use of intravenous acetaminophen
intervention group: using intravenous acetaminophen in contrast routine pethedine
in interventin group we change postoperative analgesic drug to intravenous acetaminophen
Category
Treatment - Drugs
2
Description
Control group: using routine pethedine in cotrol group we use routine opiod analgesic drug (pethedine) without change in dose or administration route.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital- Tabriz
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center of Dental Faculty- Dental and Periodontal Research Center
Full name of responsible person
Kheyraddin Pourabbas
Street address
3rd floor, Dental Faculty of Tabriz, Golgasht st.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center of Dental Faculty- Dental and Periodontal Research Center
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
Department of Maxillofacial Surgery, Faculty of Dentistry , Tabriz University of Medical Sciences
Full name of responsible person
Javad Yazdani
Position
Associate professor
Other areas of specialty/work
Street address
Department of Maxillofacial Surgery, Faculty of Dentistry , Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 5968
Fax
Email
m_ghavimi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Maxillofacial Surgery, Faculty of Dentistry , Tabriz University of Medical Sciences
Full name of responsible person
Javad Yazdani
Position
Associate professor
Other areas of specialty/work
Street address
Department of Maxillofacial Surgery, Faculty of Dentistry , Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 5968
Fax
Email
Ja-yazdani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Javad Yazdani
Position
Associated Professor of OMFS
Other areas of specialty/work
Street address
Dental faculty of Tabriz
City
Tabriz
Postal code
00984113355967
Phone
+98 41 1335 5967
Fax
Email
m_ghavimi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)