RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child
Information source: IRCCS Burlo Garofolo
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fracture; Pain
Intervention: ketorolac (Drug); tramadol (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: IRCCS Burlo Garofolo Official(s) and/or principal investigator(s):
Edoardo Guglia, md, Principal Investigator, Affiliation: IRCCS Burlo Garofolo
Overall contact:
Edoardo Guglia, md, Phone: +390403785373, Email: edigugl@gmail.com
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
Clinical Details
Official title: Randomized Controlled Trial on Effectiveness of Ketorolac and Tramadol in Not Compound Fractures of Child
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: comparison between the two groups on effectiveness on pain, measured with linear and analogic scale (see above)
Eligibility
Minimum age: 4 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Edoardo Guglia, md, Phone: +390403785373, Email: edigugl@gmail.com
IRCCS Burlo Garofolo, Trieste 34100, Italy
Additional Information
Starting date: April 2009
Ending date: October 2010
Last updated: January 28, 2009
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