Local Anesthesia for Pediatric Cochlear Implant

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721081
• Other study ID #: WBAKHET-LA
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2014
• Est. completion date: August 26, 2016

Study information

• Verified date: October 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 26, 2016
• Est. primary completion date: August 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ainshams University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Wahba bakhet	bahteem specialized hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The operative time	Minutes	Intraoperative
Secondary	The anesthesia time.	Minutes	Intraoperative
Secondary	Heart rate	beats per minute	Intraoperative
Secondary	mean arterial blood pressure	mm Hg	Intraoperative
Secondary	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
Secondary	Anesthetic consumption	propofol and remifentanil requirement after the bolus	Intraoperative