Great Auricular Nerve Block for Tympanomastoid Surgery: Will the Addition of Clonidine Enhance the Duration of Analgesia?
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tympanomastoid Surgery Cochlear Implant Mastoidectomy Cholesteatoma |
Drug: 0.25% Bupivacaine + Clonidine |
Phase 2 |
| Study Type: | Interventional |
| 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
| Enrollment: | 56 |
| Study Start Date: | February 2006 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
Publications:
| Responsible Party: | Ann & Robert H Lurie Children's Hospital of Chicago |
| ClinicalTrials.gov Identifier: | NCT01638052 History of Changes |
| Other Study ID Numbers: | CMH IRB 2005-12645 |
| Study First Received: | July 9, 2012 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
|
Tympanomastoid Surgery Cochlear Implant Mastoidectomy Cholesteatoma Pediatrics |
Clonidine Bupivacaine Greater Auricular Nerve Block Regional Anesthesia |
Additional relevant MeSH terms:
|
Cholesteatoma Keratosis Skin Diseases Bupivacaine Clonidine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
Therapeutic Uses Antihypertensive Agents Cardiovascular Agents Sympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics |
ClinicalTrials.gov processed this record on May 21, 2013