Cholesteatoma, Cochlear Implant, Mastoidectomy, Tympanomastoid Surgery
Conditions
Keywords
Tympanomastoid Surgery, Cochlear Implant, Mastoidectomy, Cholesteatoma, Pediatrics, Clonidine, Bupivacaine, Greater Auricular Nerve Block, Regional Anesthesia
Brief 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.
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.
Interventions
DRUG0.25% Bupivacaine + Clonidine
Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Observer-Rated Patient Pain Scores | 60 minutes | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Nausea/Vomiting | 24 hours | Incidence of nausea/vomiting during 24 hour observation |
| Number of Participants Requiring Use of Rescue Analgesic Medication in the Initial 24 Hours Postoperatively | 24 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.25% Bupivacaine This is our standard of care concentration | 28 |
| 0.25% Bupivacaine + Clonidine These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.
0.25% Bupivacaine + Clonidine : Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | 0.25% Bupivacaine + Clonidine | Total | 0.25% Bupivacaine |
|---|---|---|---|
| Age, Continuous | 7.5 years | 7.2 years | 6.9 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 28 Participants | 56 Participants | 28 Participants |
| Sex: Female, Male Female | 14 Participants | 28 Participants | 14 Participants |
| Sex: Female, Male Male | 14 Participants | 28 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
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).
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.25% Bupivacaine | Average Observer-Rated Patient Pain Scores | 2 units on a scale | Standard Deviation 1.05 |
| 0.25% Bupivacaine + Clonidine | Average Observer-Rated Patient Pain Scores | 1.9 units on a scale | Standard Deviation 1.05 |
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.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.25% Bupivacaine | Number of Participants Requiring Use of Rescue Analgesic Medication in the Initial 24 Hours Postoperatively | 18 Participants |
| 0.25% Bupivacaine + Clonidine | Number of Participants Requiring Use of Rescue Analgesic Medication in the Initial 24 Hours Postoperatively | 22 Participants |
Secondary
Number of Participants With Nausea/Vomiting
Incidence of nausea/vomiting during 24 hour observation
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.25% Bupivacaine | Number of Participants With Nausea/Vomiting | 14 Participants |
| 0.25% Bupivacaine + Clonidine | Number of Participants With Nausea/Vomiting | 10 Participants |