Comparison of Two Different Pain Management Techniques in Pediatric Patients Undergoing a Hernia Repair

Completed · Not applicable

Conditions studied: Pain, Inguinal Hernia

In brief

The purpose of this research study is to find the best way to decrease pain in children right after surgery whom have had their hernia fixed. Right now, there are two different ways surgeons and anesthesia providers try to decrease pain. It is not clear if one way is better than the other. The method used is often chosen by which one the doctor has more experience using. The Investigator plans to find out if one of the methods is more effective and/or safer than the other method. The results of this study will help learn how to best control pain in children having surgery for hernia repair.

Key facts

Study ID

NCT01740193

Run by

Children's Hospital Medical Center, Cincinnati

People needed

59

Starts

2012-08-01

Expected to finish

2017-12-01

Last updated by the study team

2018-12-19

Who can join

Age: 1 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is male or female;
• The subject is of any racial and ethnic groups;
• The subject is age 12 months to 10 years (inclusive);
• The subject weighs more than 8.0 kg (inclusive of the eighth kilogram);
• The subject is scheduled for the following: Unilateral herniorrhaphy scheduled on an out-patient basis, and not being performed in conjunction with any other surgical procedures;
• The subject is American Society of Anesthesiologists (ASA) patient classification I-II
• The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.

You may not qualify if…

• Additional surgical procedures are being performed concurrently;
• The subject is ASA classification > II;
• The subject has pre-existing allergies to local anesthetics;
• The subject receives midazolam as a premedication;
• The subject has an imminent life threatening condition that impacts the ability to obtain informed consent;
• The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study.

Where it is running

• Cincinnati Children's Hosptial Medical Center - Liberty Campus — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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