RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child
Primary Purpose
Fracture, Pain
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
ketorolac
tramadol
Sponsored by
About this trial
This is an interventional treatment trial for Fracture focused on measuring bone fracture, ketorolac, tramadol
Eligibility Criteria
Inclusion Criteria:
- Children 4-17 years old with not compound bone fracture presenting in emergency room
Exclusion Criteria:
- Compound fracture
- Occurring pain still treated
- Contraindicated ketorolac or tramadol use
- Informed consensus not obtained
Sites / Locations
- IRCCS Burlo Garofolo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
children 4-17 y. old with not compound bone fracture treated with ketorolac
children 4-17 y. old with not compound bone fracture treated with tramadol
Outcomes
Primary Outcome Measures
estimation of pain reduction in every arm of the trial with linear 1-10 pain scale or for children 4 - 6 years old with analogic MacGrath type scale
Secondary Outcome Measures
comparison between the two groups on effectiveness on pain, measured with linear and analogic scale (see above)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00560443
Brief Title
RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child
Official Title
Randomized Controlled Trial on Effectiveness of Ketorolac and Tramadol in Not Compound Fractures of Child
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2008 (Actual)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Burlo Garofolo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomized double blind Trial with the aim to estimate effectiveness of two therapeutic regimes per os on pain due to not compound bone fractures in child 4-17 years old:
ketorolac 0,5 mg/kg (1 drop every 2 Kg)
tramadol 2,5 mg/Kh (1 drop every 2 Kg)
Intensity of pain will be estimated with linear 1 to 10 or analogic McGrath type scale every 20 min.
The main objectives are the evaluation of pain decreasing in every group, the time of decreasing, the intensity of pain during procedures (ex. Xray) and the occurrence of side effects Secondary outcomes are comparison between the two groups on effectiveness on pain and on side effects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture, Pain
Keywords
bone fracture, ketorolac, tramadol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
children 4-17 y. old with not compound bone fracture treated with ketorolac
Arm Title
2
Arm Type
Experimental
Arm Description
children 4-17 y. old with not compound bone fracture treated with tramadol
Intervention Type
Drug
Intervention Name(s)
ketorolac
Intervention Description
0,5 mg/kg per os one time
Intervention Type
Drug
Intervention Name(s)
tramadol
Intervention Description
2,5 mg/ kg per os in one dose
Primary Outcome Measure Information:
Title
estimation of pain reduction in every arm of the trial with linear 1-10 pain scale or for children 4 - 6 years old with analogic MacGrath type scale
Time Frame
6 hours (or until the end of procedures)
Secondary Outcome Measure Information:
Title
comparison between the two groups on effectiveness on pain, measured with linear and analogic scale (see above)
Time Frame
6 hours or until the end of procedures
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children 4-17 years old with not compound bone fracture presenting in emergency room
Exclusion Criteria:
Compound fracture
Occurring pain still treated
Contraindicated ketorolac or tramadol use
Informed consensus not obtained
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edoardo Guglia, md
Organizational Affiliation
IRCCS Burlo Garofolo
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Burlo Garofolo
City
Trieste
ZIP/Postal Code
34100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
23702435
Citation
Neri E, Maestro A, Minen F, Montico M, Ronfani L, Zanon D, Favret A, Messi G, Barbi E. Sublingual ketorolac versus sublingual tramadol for moderate to severe post-traumatic bone pain in children: a double-blind, randomised, controlled trial. Arch Dis Child. 2013 Sep;98(9):721-4. doi: 10.1136/archdischild-2012-303527. Epub 2013 May 23.
Results Reference
derived
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RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child
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