The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children
Information source: Children's Hospital of Eastern Ontario
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hernia, Inguinal; Hydrocele
Intervention: clonidine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Children's Hospital of Eastern Ontario Official(s) and/or principal investigator(s): Kimmo Murto, MD, Principal Investigator, Affiliation: Children's Hospital of Eastern Ontario
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.
Clinical Details
Official title: The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Time to first analgesia after procedure
Secondary outcome: 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
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
Minimum age: 1 Year.
Maximum age: 12 Years.
Gender(s): Both.
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
Locations and Contacts
Children's Hospital of Eastern Ontario, Ottawa, Ontario K1H 8L1, Canada
Additional Information
Link to Children's Hospital of Eastern Ontario anesthesiology research page.
Starting date: September 2009
Last updated: February 18, 2015
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