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

NCT00130091 | Completed Phase 2 DMC

• 1 other identifier: 05/17E
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Inguinal; Hydrocele

Keywords

unilateral; hernia; hydrocele; pediatric; clonidine; nerve block

Outcome Measures

Primary Outcomes (1)

• Time to first analgesia after procedure

  24 hours

Secondary Outcomes (5)

• continuous pain scores (modified Children's Hospital of Eastern Ontario Pain Score [mCHEOPS], modified Wong-Baker Faces)

  baseline plus seven days

• sedation scores

  Between 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 consumed

  seven days

• total sedation consumed

  Between surgery and surgical day unit discharge (approx four hours)

Study Arms (2)

Clonidine

EXPERIMENTAL

administer with local anesthetic

Drug: clonidine

Local anesthetic

PLACEBO COMPARATOR

Local anesthetic without clonidine

Drug: clonidine

Interventions

clonidine DRUG

2 mcg clonidine added to local anesthetic

Clonidine; Local anesthetic

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Unilateral inguinal hernia or hydrocele
• to 12 years old
• American Society of Anesthesiology classification I-II
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Hernia, Inguinal; Testicular Hydrocele; Hernia

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kimmo Murto, MD

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCPC, Dept. Anesthesiology CHEO, Assistant Professor, University of Ottawa

Study Record Dates

• First Submitted: August 11, 2005
• First Posted: August 15, 2005
• Study Start: September 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 20, 2015

Record last verified: 2015-02

Locations

CA (1)