Local Anesthesia for Pediatric Cochlear Implant

Wahba bakhet

Status and phase

Completed

Phase 4

Conditions

Anesthesia, Local

Treatments

Drug: Lidocaine 1%/Epi 1:200000

Other: Na Cl 0.9%/Epi 1:200000

Study type

Interventional

Funder types

Other

Identifiers

NCT03721081

WBAKHET-LA

Details and patient eligibility

About

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).

Full 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.

Enrollment

70 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.