RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child

NCT00560443 | Completed Phase 4 DMC

• 1 other identifier: RC 30/07
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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

Conditions

Fracture; Pain

Keywords

bone fracture; ketorolac; tramadol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: ketorolac

2

EXPERIMENTAL

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

Drug: tramadol

Interventions

ketorolac DRUG

0,5 mg/kg per os one time

1

tramadol DRUG

2,5 mg/ kg per os in one dose

2

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 4-17 years old with not compound bone fracture presenting in emergency room

You may not qualify if:

• Compound fracture
• Occurring pain still treated
• Contraindicated ketorolac or tramadol use
• Informed consensus not obtained

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, 34100, Italy

Location

Related Publications (1)

• 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.

  PMID: 23702435 DERIVED

MeSH Terms

Conditions

Fractures, Bone; Pain

Interventions

Ketorolac; Tramadol

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Edoardo Guglia, md

  IRCCS Burlo Garofolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 19, 2007
• Study Start: February 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 24, 2017

Record last verified: 2017-08

Locations

IT (1)