Great Auricular Nerve Block for Tympanomastoid Surgery: Will the Addition of Clonidine Enhance the Duration of Analgesia?
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.
Drug: 0.25% Bupivacaine + Clonidine
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery: Does the Addition of Clonidine Increase the Duration of Postoperative Analgesia?|
- Duration of greater auricular nerve block [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Patients will be observed using a CHIPPS (Children and Infants Postoperative Pain Scale) pain survey
- Nausea/Vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Incidence of nausea/vomiting during 24 hour observation
- Need for rescue analgesic [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Use of rescue analgesic in hospital and by parents at home
- Hemodynamics [ Time Frame: 1 hour ] [ Designated as safety issue: No ]Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate measured pre- and post-block
|Study Start Date:||February 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
No Intervention: 0.25% Bupivacaine
This is our standard of care concentration
Experimental: 0.25% Bupivacaine + Clonidine
These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.
Drug: 0.25% Bupivacaine + Clonidine
Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638052
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital of Chicago|
|Chicago, Illinois, United States, 60611|