Local Anesthesia for Pediatric Cochlear Implant

Study Overview
=================
Brief Summary
-----------------
Propofol with remifentanil provides good operative conditions for pediatric cochlear implant (CI); however, large doses of remifentanil usually result in postoperative hyperalgesia and increase postoperative pain. Local anesthesia (LA) is commonly used as an adjunct to general anesthesia in children; however, otologists are usually reluctant in the use of LA as it can cause abolishment of the electrical stapedial reflex threshold (ESRT).

Detailed Description
-----------------
Seventy children (1-6 years) undergoing CI were recruited. Children were divided into two groups. The LA group received subcutaneous infiltration of 0.5 ml/kg lidocaine 1% in adrenaline 1:200,000 and the CT group received 0.5 ml/kg of Na CI 0.9% in adrenaline 1:200,000. The primary outcome was number of patients requiring rescue analgesia (tramadol) during the first 24-h postoperative. Secondary outcomes were haemodynamic variables, the ESRT, intraoperative anesthetic requirements, time to LMA removal, time to total recovery, pain scores, time to first rescue analgesia and incidence of vomiting.

Official Title
-----------------
Preemptive Local Anesthetic Infiltration Reduces Opioid Requirements Without Attenuation of the Intraoperative Evoked Stapedial Reflex Thresholds in Pediatric Cochlear Implant Surgery

Conditions
-----------------
Anesthesia, Local

Intervention / Treatment
-----------------
* Drug: Lidocaine 1%/Epi 1:200000
* Other: Na Cl 0.9%/Epi 1:200000


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II physical status, age between 1 and 6 year, Exclusion Criteria: known allergy to local anesthetics, predicted operative difficulty (i.e. syndromic hearing loss, congenital cochlear abnormalities or cochlear ossification.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Na Cl 0.9%/Epi 1:200000<br>Subcutaneous infiltration of Na Cl 0.9%/Epi 1:200000 | Other: Na Cl 0.9%/Epi 1:200000<br>* Five minutes before skin incision, subcutaneous infiltration of 0.5 ml/kg of Na CI 0.9%/Epi 1:200000 inj along a 3 cm extended endaural incision with a 23 G hypodermic needle administered was performed by the surgeon, who was blinded to the applied drug solution.<br>|
| Active Comparator: Lidocaine 1%/Epi 1:200000<br>Subcutaneous infiltration of Lidocaine 1%/Epi 1:200000 | Drug: Lidocaine 1%/Epi 1:200000<br>* Five minutes before skin incision, subcutaneous infiltration of 0.5 ml/kg of Lidocaine 1%/Epi 1:200000 Inj along a 3 cm extended endaural incision with a 23 G hypodermic needle administered was performed by the surgeon, who was blinded to the applied drug solution.<br>* Other names: Xylocaine 1%/Epi 1:200000;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients requiring rescue opioid analgesia (Tramal) | Post-operative Pain assessed by the pediatric observational Faces, Legs, Activity, Cry Consolability (FLACC) score with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain) | During the length of hospital stay post surgery (on average 24 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The operative time | Minutes | Intraoperative | 
| The anesthesia time. | Minutes | Intraoperative | 
| Heart rate | beats per minute | Intraoperative | 
| mean arterial blood pressure | mm Hg | Intraoperative | 
| ESRT responses | The surgeon assessed ESRT response at the basal, middle, and apical areas of the electrode array by visual monitoring of the stapedius muscle using direct microscopic examination | Intraoperative | 
| Anesthetic consumption | propofol and remifentanil requirement after the bolus | Intraoperative |