RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child

IRCCS Burlo Garofolo

Status and phase: Completed; Phase 4

Conditions: Fracture; Pain

Treatments: Drug: tramadol; Drug: ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT00560443

RC 30/07

Details and patient eligibility

About

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

Enrollment: 133 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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133 participants in 2 patient groups

1

Active Comparator group

Description:

children 4-17 y. old with not compound bone fracture treated with ketorolac

Treatment:

Drug: ketorolac

2

Experimental group

Description:

children 4-17 y. old with not compound bone fracture treated with tramadol

Treatment:

Drug: tramadol