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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00560443
Other study ID # RC 30/07
Secondary ID
Status Completed
Phase Phase 4
First received November 7, 2007
Last updated August 23, 2017
Start date February 2008
Est. completion date April 2012

Study information

Verified date August 2017
Source IRCCS Burlo Garofolo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender All
Age group 4 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ketorolac
0,5 mg/kg per os one time
tramadol
2,5 mg/ kg per os in one dose

Locations

Country Name City State
Italy IRCCS Burlo Garofolo Trieste

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 hours (or until the end of procedures)
Secondary comparison between the two groups on effectiveness on pain, measured with linear and analogic scale (see above) 6 hours or until the end of procedures
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