Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tympanomastoid Surgery, Cochlear Implant, Mastoidectomy, Cholesteatoma

Intervention / Treatment
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* Drug: 0.25% Bupivacaine + Clonidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 0.25% Bupivacaine<br>This is our standard of care concentration | |
| Experimental: 0.25% Bupivacaine + Clonidine<br>These are not two separate drugs, but a mixture of Bupivacaine and Clonidine. | Drug: 0.25% Bupivacaine + Clonidine<br>* Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine<br>* Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Nausea/Vomiting | Incidence of nausea/vomiting during 24 hour observation | 24 hours | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tympanomastoid Surgery, Cochlear Implant, Mastoidectomy, Cholesteatoma, Pediatrics, Clonidine, Bupivacaine, Greater Auricular Nerve Block, Regional Anesthesia