NCT01638052

Brief Summary

The investigators goal is to determine the efficacy and duration of analgesia with the addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing tympanomastoid surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
9 years until next milestone

Results Posted

Study results publicly available

July 7, 2021

Completed
Last Updated

August 4, 2021

Status Verified

July 1, 2012

Enrollment Period

2.1 years

First QC Date

July 9, 2012

Results QC Date

December 23, 2020

Last Update Submit

August 2, 2021

Conditions

Tympanomastoid SurgeryCochlear ImplantMastoidectomyCholesteatoma

Keywords

Tympanomastoid SurgeryCochlear ImplantMastoidectomyCholesteatomaPediatricsClonidineBupivacaineGreater Auricular Nerve BlockRegional Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Average Observer-Rated Patient Pain Scores

    Patients will be observed with behaviors rated at regular time intervals using the CHIPPS (Children and Infants Postoperative Pain Scale) pain survey. The CHIPPS scale values range from a minimum of 0 (no pain, better outcome) to a maximum of 10 (worst pain, worse outcome).

    60 minutes

Secondary Outcomes (2)

  • Number of Participants With Nausea/Vomiting

    24 hours

  • Number of Participants Requiring Use of Rescue Analgesic Medication in the Initial 24 Hours Postoperatively

    24 hours

Study Arms (2)

0.25% Bupivacaine

NO INTERVENTION

This is our standard of care concentration

0.25% Bupivacaine + Clonidine

EXPERIMENTAL

These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.

Drug: 0.25% Bupivacaine + Clonidine

Interventions

0.25% Bupivacaine + ClonidineDRUG

Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine

Also known as: Marcaine
0.25% Bupivacaine + Clonidine

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 1-18 years
  • tympanomastoid surgery (cochlear implant, mastoidectomy, cholesteatoma surgery)
  • ASA I, II
  • informed consent and assent obtained

You may not qualify if:

  • allergic to local anesthestic
  • taking chronic aspirin or Ibuprofen therapy
  • ASA IV
  • history of clinically important renal, hepatic, respiratory, cardiac, or neurological conditions
  • Patients who have cardiovascular surgery other than an atrial septal defect or a ventricular septal defect, or who have undergone complete corrective intracardiac repair of congenital heart disease.
  • Informed consent not obtained
  • Patients expected to receive dexamethasone or ondansetron intra-operative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

  • Suresh S, Barcelona SL, Young NM, Seligman I, Heffner CL, Cote CJ. Postoperative pain relief in children undergoing tympanomastoid surgery: is a regional block better than opioids? Anesth Analg. 2002 Apr;94(4):859-62, table of contents. doi: 10.1097/00000539-200204000-00015.

    PMID: 11916785BACKGROUND

  • Wheeler M, Patel A, Suresh S, Roth AG, Birmingham PK, Heffner CL, Cote CJ. The addition of clonidine 2 microg.kg-1 does not enhance the postoperative analgesia of a caudal block using 0.125% bupivacaine and epinephrine 1:200,000 in children: a prospective, double-blind, randomized study. Paediatr Anaesth. 2005 Jun;15(6):476-83. doi: 10.1111/j.1460-9592.2005.01481.x.

    PMID: 15910348BACKGROUND

MeSH Terms

Conditions

Cholesteatoma

Interventions

BupivacaineClonidine

Condition Hierarchy (Ancestors)

KeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Santhanam Suresh, MD
Organization
Ann & Robert H. Lurie Children's Hospital of Chicago
SSuresh@luriechildrens.org
312-227-5147

Study Officials

  • Santhanam Suresh, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 11, 2012

Study Start

February 1, 2006

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

August 4, 2021

Results First Posted

July 7, 2021

Record last verified: 2012-07

Locations

US(1)