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The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children
This study is not yet open for participant recruitment.
Verified by Children's Hospital of Eastern Ontario, August 2005
Sponsored by: Children's Hospital of Eastern Ontario
Information provided by: Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT00130091
  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 II

MedlinePlus related topics: Hernia
Drug Information available for: Clonidine Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride Clonidine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

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

Primary Outcome Measures:
  • time to first analgesia

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

Estimated Enrollment: 128
Study Start Date: September 2005
Estimated Study Completion Date: September 2006
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 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Unilateral inguinal hernia or hydrocele
  • 1 to 13 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
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
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Investigators
Principal Investigator: Kimmo Murto, MD Children's Hospital of Eastern Ontario
  More Information

Study ID Numbers: 05/17E
Study First Received: August 11, 2005
Last Updated: September 22, 2005
ClinicalTrials.gov Identifier: NCT00130091  
Health Authority: Canada: Health Canada

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

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Ropivacaine
Hernia
Clonidine
Hernia, Abdominal
Testicular Hydrocele
Genital Diseases, Male
Hernia, Inguinal

Additional relevant MeSH terms:
Sympatholytics
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009