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

Primary Purpose

Hernia, Inguinal, Hydrocele

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
clonidine
Sponsored by
Children's Hospital of Eastern Ontario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring unilateral, hernia, hydrocele, pediatric, clonidine, nerve block

Eligibility Criteria

1 Year - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's Hospital of Eastern Ontario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Clonidine

Local anesthetic

Arm Description

administer with local anesthetic

Local anesthetic without clonidine

Outcomes

Primary Outcome Measures

Time to first analgesia after procedure

Secondary Outcome Measures

continuous pain scores (modified Children's Hospital of Eastern Ontario Pain Score [mCHEOPS], modified Wong-Baker Faces)
sedation scores
emergence delirium score (Pediatric Anesthesia Emergence Delirium [PAED])
total analgesics consumed
total sedation consumed

Full Information

First Posted
August 11, 2005
Last Updated
February 18, 2015
Sponsor
Children's Hospital of Eastern Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT00130091
Brief Title
The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children
Official Title
The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Eastern Ontario

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal, Hydrocele
Keywords
unilateral, hernia, hydrocele, pediatric, clonidine, nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clonidine
Arm Type
Experimental
Arm Description
administer with local anesthetic
Arm Title
Local anesthetic
Arm Type
Placebo Comparator
Arm Description
Local anesthetic without clonidine
Intervention Type
Drug
Intervention Name(s)
clonidine
Intervention Description
2 mcg clonidine added to local anesthetic
Primary Outcome Measure Information:
Title
Time to first analgesia after procedure
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
continuous pain scores (modified Children's Hospital of Eastern Ontario Pain Score [mCHEOPS], modified Wong-Baker Faces)
Time Frame
baseline plus seven days
Title
sedation scores
Time Frame
Between surgery and surgical day unit discharge (approx four hours)
Title
emergence delirium score (Pediatric Anesthesia Emergence Delirium [PAED])
Time Frame
Between surgery and surgical day unit discharge (approx four hours)
Title
total analgesics consumed
Time Frame
seven days
Title
total sedation consumed
Time Frame
Between surgery and surgical day unit discharge (approx four hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimmo Murto, MD
Organizational Affiliation
Children's Hospital of Eastern Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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