The Objective of this study is to compare the analgesic effect of oral acetaminophen and ibuprofen in children with humerus supracondylar fracture. This study is design as a clinical trial. In this study children with supracondylar fracture will be enrolled. They will be divided into two groups regard to random block method. Children with supracondylar fractures will be enrolled the study and exclusion criteria are history of gastrointestinal (GI) bleeding or GI ulcers; low platelet count; renal disease; significant allergy for Acetaminophen or Ibuprofen and underlying chronic diseases. First group will receive Acetaminophen about 10 mg/kg every 4-6 hours (with maximum dose 400 mg) and the second one will receive 10/kg/day Ibuprofen in 3 or 4 divided dose. Patients’ pain will be evaluated after 2, 4 and 12 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100811956N7
Registration date:2017-06-11, 1396/03/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-11, 1396/03/21
Registrant information
Name
Morteza Talebi Doluee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5312
Email address
talebidm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2017-06-15, 1396/03/25
Expected recruitment end date
2017-07-08, 1396/04/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
analgesic effect of oral acetaminophen and ibuprofen in children with humerus supracondylar fracture
Public title
Comparison the analgesic effect of oral acetaminophen and ibuprofen in children with humerus supracondylar fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Children with supracondylar fractures will be enrolled the study and exclusion criteria are history of gastrointestinal (GI) bleeding or GI ulcers; low platelet count; renal disease; significant allergy for Acetaminophen or Ibuprofen and underlying chronic diseases.
Age
To 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences ethical committee
Street address
Ghoreyshi Building, Daneshgah Strees, Mashhad
City
Mashhad
Postal code
Approval date
2016-05-26, 1395/03/06
Ethics committee reference number
IR.MUMS.fm.REC.237
Health conditions studied
1
Description of health condition studied
Fracture of lower end of humerus
ICD-10 code
S42.4
ICD-10 code description
Fracture of lower end of humerus
Primary outcomes
1
Description
Pain severity
Timepoint
2 hours, 4 hours and 12 hours
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Acetaminophen about 10 mg/kg every 4-6 hours (with maximum dose 400 mg)