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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01294098
Other study ID # 10-0331
Secondary ID
Status Terminated
Phase N/A
First received February 9, 2011
Last updated March 28, 2018
Start date February 2011
Est. completion date October 8, 2014

Study information

Verified date March 2018
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the efficacy of the use of Marcaine in femoral nerve blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a pediatric population.


Description:

Children with femur fractures can have severe pain after elastic nail fixation. The current national standard for post operative pain control would be intravenous narcotics. In addition to the use of intravenous narcotics, there are two alternative methods used during the surgery in order to potentially decrease the pain post-operatively. These methods are hematoma block or a femoral nerve block. Both are proven safe and effective in children, however little research has been done to look at the effectiveness of these various methods compared to one another.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date October 8, 2014
Est. primary completion date October 8, 2013
Accepts healthy volunteers No
Gender All
Age group 7 Years to 14 Years
Eligibility Inclusion Criteria:

- A child with a femoral shaft fracture requiring surgical treatment and the placement of intramedullary nails

- Weight of 30-100 Kg

- Child must be older than 6 years old

Exclusion Criteria:

- Any child that had an open fracture

- A child that has a pain abnormality

- Any child with an allergy to local anesthetic

- Any child with a neurological injury

- Any child with the inability to report pain

- Any child that is unable to use a PCA post-operatively

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Marcaine
0.75 cc/kg of 1/4% Marcaine

Locations

Country Name City State
United States St. Louis Childrens Hospital Saint Louis Missouri
United States Washington University Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative Pain Scores We will be looking at post-operative pain scores to see if those in the intervention group have lower pains scores.
Wong Baker FACES pain scale:The faces correspond to numeric values from 0-5. This scale can be documented with the numeric value. The pain scale goes from 0-5 with 0 being no pain and 5 being the worst pain.
0: No Hurt
Hurts a little bit
Hurts a little more
Hurts even more
Hurts a whole lot
Hurts worst
with in the first 24 hours
Primary Post-operative Narcotic Use We will be looking at the amount of narcotics used after surgery to see if there is a reduction in narcotic use within first 24 horus
Secondary Femur Fracture Healing we will following patients to look at fracture healing post-operatively first year
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