Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery

Cochlear Implant Clinical Trial

Official title:

Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery: Does the Addition of Clonidine Increase the Duration of Postoperative Analgesia?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638052
• Other study ID #: CMH IRB 2005-12645
• Status: Completed
• Phase: Phase 2
• Start date: February 2006
• Est. completion date: April 2008

Study information

• Verified date: July 2012
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The surgical anesthesia during the operative procedure will be maintained using volatile anesthetics. No prophylactic dexamethasone or ondansetron would be provided to any patients in either group. Anesthesia will be discontinued at the end of the procedure and the patient will be extubated once standard extubation criteria have been met. Patients will be then taken to the postoperative recovery room where they will be evaluated for pain and discomfort by a blinded observer using the CHIPPS (Children and Infants Postoperative Pain Scale). If two consecutive pain scores at 5 minute intervals is >6, they will be rescued with incremental doses of 0.05 mg/kg of intravenous morphine required to reach a score of <6. The number of rescue doses as well as the pain scores will be documented. These patients will be also observed for the presence of nausea/vomiting. Any patient who vomits more than two times will be rescued with ondansetron 0.1 mg/kg intravenously. All patients will be continued to be evaluated in the 23 hour unit. Pain and side effects will be assessed for the next 6 hours or until discharge from the 23 hour observation facility. Standard doses of acetaminophen with codeine will be provided for pain relief in the 23 hour observational unit, as well as on discharge. The number of doses of acetaminophen with codeine will be recorded. Time to discharge from the hospital will also be noted. A questionnaire designed to address parent/patient satisfaction will be utilized and will allude to the need for rescue analgesia and the need for any other additional analgesics provided. The use of any additional rescue pain medication will be provided to the families at the time of discharge. A follow-up phone call will be made in 24 hours to note the information provided on the questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• age 1-18 years

• tympanomastoid surgery (cochlear implant, mastoidectomy, cholesteatoma surgery)

• ASA I, II

• informed consent and assent obtained

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cholesteatoma
• Cochlear Implant
• Mastoidectomy
• Tympanomastoid Surgery

Intervention

Drug:
• 0.25% Bupivacaine + Clonidine
Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (2)

Suresh S, Barcelona SL, Young NM, Seligman I, Heffner CL, Coté 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. — View Citation

Wheeler M, Patel A, Suresh S, Roth AG, Birmingham PK, Heffner CL, Coté 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Nausea/Vomiting	Incidence of nausea/vomiting during 24 hour observation	24 hours
Secondary	Number of Participants Requiring Use of Rescue Analgesic Medication in the Initial 24 Hours Postoperatively	Count of participants who will require use of rescue analgesic medication in the initial 24 hours postoperatively as recorded in the hospital or by parents at home following discharge.	24 hours