NCT03721081

Local Anesthesia for Pediatric Cochlear Implant

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Wahba bakhet · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Anesthesia, Local

Interventions

Type	Name	Description
DRUG	Lidocaine 1%/Epi 1:200000	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.
OTHER	Na Cl 0.9%/Epi 1:200000	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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-08-26
• Completion: 2016-08-26
• First posted: 2018-10-26
• Last updated: 2019-10-29

Locations

1 site across 1 country: Egypt