Phase 2
Completed N=56
Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery
Tympanomastoid Surgery · Cochlear Implant · Mastoidectomy · cholesteatoma
Source: ClinicalTrials.gov NCT01638052 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Average Observer-Rated Patient Pain Scores — 2; 1.9 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Observer-Rated Patient Pain Scores |
2; 1.9 | — |
| SECONDARY Number of Participants With Nausea/Vomiting |
14; 10 | — |
| SECONDARY Number of Participants Requiring Use of Rescue Analgesic Medication in the Initial 24 Hours Postoperatively |
18; 22 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01638052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.