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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Children's Hospital of Eastern Ontario
Sponsor:
Information provided by (Responsible Party):
Kimmo Murto, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT00130091
First received: August 11, 2005
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Hernia, Inguinal
Hydrocele
Drug: clonidine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • Time to first analgesia after procedure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • continuous pain scores (modified Children's Hospital of Eastern Ontario Pain Score [mCHEOPS], modified Wong-Baker Faces) [ Time Frame: baseline plus seven days ] [ Designated as safety issue: No ]
  • sedation scores [ Time Frame: Between surgery and surgical day unit discharge (approx four hours) ] [ Designated as safety issue: No ]
  • emergence delirium score (Pediatric Anesthesia Emergence Delirium [PAED]) [ Time Frame: Between surgery and surgical day unit discharge (approx four hours) ] [ Designated as safety issue: No ]
  • total analgesics consumed [ Time Frame: seven days ] [ Designated as safety issue: No ]
  • total sedation consumed [ Time Frame: Between surgery and surgical day unit discharge (approx four hours) ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: September 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   1 Year to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130091

Contacts
Contact: Kimmo Murto, MD 613-737-2431 kmurto@cheo.on.ca

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Kimmo Murto, MD    613-737-2431    kmurto@cheo.on.ca   
Contact: Jarmila Kim, MD    613-737-7600 ext 3144    Jkim@cheo.on.ca   
Principal Investigator: Kimmo Murto, MD         
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Investigators
Principal Investigator: Kimmo Murto, MD Children's Hospital of Eastern Ontario
  More Information

Additional Information:
No publications provided

Responsible Party: Kimmo Murto, MD, FRCPC, Dept. Anesthesiology CHEO, Assistant Professor, University of Ottawa, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT00130091     History of Changes
Other Study ID Numbers: 05/17E
Study First Received: August 11, 2005
Last Updated: April 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by Children's Hospital of Eastern Ontario:
unilateral
hernia
hydrocele
pediatric
clonidine
nerve block

Additional relevant MeSH terms:
Hernia, Inguinal
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Anesthetics
Ropivacaine
Anesthetics, Local
Clonidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014