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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00130091
Enrollment
120
Registered
2005-08-15
Start date
2009-09-30
Completion date
2014-12-31
Last updated
2015-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Inguinal, Hydrocele

Keywords

unilateral, hernia, hydrocele, pediatric, clonidine, nerve block

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.

Interventions

DRUGclonidine

2 mcg clonidine added to local anesthetic

Sponsors

Children's Hospital of Eastern Ontario
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Time to first analgesia after procedure24 hours

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026