The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children

February 18, 2015 updated by: Kimmo Murto, Children's Hospital of Eastern Ontario
The current study will compare the effects on postoperative pain relief of "freezing" (ropivacaine 0.2 %) alone and in combination with clonidine for a nerve block in children undergoing hernia repair. The researchers anticipate that the addition of clonidine to "freezing" will result in prolongation of postoperative pain relief in children undergoing hernia repair compared to "freezing" used alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The optimal method of controlling postoperative pain in children undergoing hernia repair would effectively relieve pain for extended periods of time and have no adverse effects. Unfortunately, such an ideal technique does not exist.

The control of postoperative pediatric pain after hernia repair is achieved with a combination of oral and intravenous pain medications and "nerve blocks". "Nerve blocks" are achieved by injecting local anesthetics or what is commonly referred to as "freezing "next to the nerve supply of the wound. "Freezing" the major nerves supplying sensation at the site of hernia repair in children, while they are asleep, is effective. At CHEO, this technique in addition to administering ketorolac, a liquid intravenous form of an anti-inflammatory agent similar to Advil, is the current technique of choice for postoperative pain control after inguinal hernia.

It is not unusual for these patients to require extra pain medications postoperatively. Available means of pain control in addition to those mentioned above include codeine-like medications, Tylenol, Advil-like medications and opioids administered intravenously. The addition of these medications increases the risk of suffering from side effects including respiratory depression, nausea and vomiting, and itching.

Ideally, the prolongation of postoperative pain relief by the addition of a second medication to the "freezing" during the nerve block would limit the need for additional pain medication and hence, decrease their associated side effects. Clonidine has the potential to be such a medication. It has been shown to provide pain relief by affecting several areas of the nervous system including the brain, the spinal cord and nerves. Clonidine prolongs pain relief of certain local anesthetics when used in nerve blocks for adults. Unfortunately, there are no studies that have examined the combination of clonidine and the local anesthetic ropivacaine for nerve blocks in children. Presently, the injectable form of clonidine is not marketed and is considered investigational in Canada.

The current study will be a prospective double -blind, randomized, controlled trial. It will compare the effects on postoperative pain relief of "freezing" (ropivacaine 0.2 %) alone and in combination with clonidine for a nerve block in children undergoing hernia repair. In addition, it will measure changes in the child's level of sedation, breathing, heart rate, blood pressure and any complications. Finally, it will assess how satisfied the parents are with this technique.

The researchers anticipate that the addition of clonidine to "freezing" will result in prolongation of postoperative pain relief in children undergoing hernia repair compared to "freezing" used alone.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unilateral inguinal hernia or hydrocele
  • 1 to 12 years old
  • American Society of Anesthesiology classification I-II
  • Written informed consent

Exclusion Criteria:

  • Exclusion to nerve block
  • Clotting disorder
  • Infection
  • Known allergy to clonidine or ropivacaine
  • History of chronic, therapeutic administration of analgesics
  • Receiving medications for attention deficit hyperactivity disorder
  • Patients taking oral clonidine
  • Undergoing bilateral hernia repair
  • Morbid obesity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clonidine
administer with local anesthetic
Drug: clonidine
2 mcg clonidine added to local anesthetic
Placebo Comparator: Local anesthetic
Local anesthetic without clonidine
Drug: clonidine
2 mcg clonidine added to local anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first analgesia after procedure
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
continuous pain scores (modified Children's Hospital of Eastern Ontario Pain Score [mCHEOPS], modified Wong-Baker Faces)
Time Frame: baseline plus seven days
baseline plus seven days
sedation scores
Time Frame: Between surgery and surgical day unit discharge (approx four hours)
Between surgery and surgical day unit discharge (approx four hours)
emergence delirium score (Pediatric Anesthesia Emergence Delirium [PAED])
Time Frame: Between surgery and surgical day unit discharge (approx four hours)
Between surgery and surgical day unit discharge (approx four hours)
total analgesics consumed
Time Frame: seven days
seven days
total sedation consumed
Time Frame: Between surgery and surgical day unit discharge (approx four hours)
Between surgery and surgical day unit discharge (approx four hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Eastern Ontario

Investigators

  • Principal Investigator: Kimmo Murto, MD, Children's Hospital of Eastern Ontario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 11, 2005

First Submitted That Met QC Criteria

August 11, 2005

First Posted (Estimate)

August 15, 2005

Study Record Updates

Last Update Posted (Estimate)

February 20, 2015

Last Update Submitted That Met QC Criteria

February 18, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/17E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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