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

Hernia, Inguinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130091
• Other study ID #: 05/17E
• Status: Completed
• Phase: Phase 2
• First received: August 11, 2005
• Last updated: February 18, 2015
• Start date: September 2009
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia, Inguinal
• Hydrocele

Intervention

Drug:
• clonidine
2 mcg clonidine added to local anesthetic

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first analgesia after procedure		24 hours	No
Secondary	continuous pain scores (modified Children's Hospital of Eastern Ontario Pain Score [mCHEOPS], modified Wong-Baker Faces)		baseline plus seven days	No
Secondary	sedation scores		Between surgery and surgical day unit discharge (approx four hours)	No
Secondary	emergence delirium score (Pediatric Anesthesia Emergence Delirium [PAED])		Between surgery and surgical day unit discharge (approx four hours)	No
Secondary	total analgesics consumed		seven days	No
Secondary	total sedation consumed		Between surgery and surgical day unit discharge (approx four hours)	No

External Links

•   Link to Children's Hospital of Eastern Ontario anesthesiology research page.