RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child

Pain Clinical Trial

Official title:

Randomized Controlled Trial on Effectiveness of Ketorolac and Tramadol in Not Compound Fractures of Child

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560443
• Other study ID #: RC 30/07
• 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
• 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

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone
• Pain

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