Local Anesthesia for Pediatric Cochlear Implant

NCT03721081 | Completed Phase 4 DMC

• 1 other identifier: WBAKHET-LA
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The operative time

  Intraoperative

• The anesthesia time.

  Intraoperative

• Heart rate

  Intraoperative

• mean arterial blood pressure

  Intraoperative

• ESRT responses

  Intraoperative

Study Arms (2)

Na Cl 0.9%/Epi 1:200000

PLACEBO COMPARATOR

Subcutaneous infiltration of Na Cl 0.9%/Epi 1:200000

Other: Na Cl 0.9%/Epi 1:200000

Lidocaine 1%/Epi 1:200000

ACTIVE COMPARATOR

Subcutaneous infiltration of Lidocaine 1%/Epi 1:200000

Drug: Lidocaine 1%/Epi 1:200000

Interventions

Lidocaine 1%/Epi 1:200000 DRUG

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.

Also known as: Xylocaine 1%/Epi 1:200000

Lidocaine 1%/Epi 1:200000

Na Cl 0.9%/Epi 1:200000 OTHER

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.

Na Cl 0.9%/Epi 1:200000

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II physical status,
• age between 1 and 6 year,

You may not qualify if:

• known allergy to local anesthetics,
• predicted operative difficulty (i.e. syndromic hearing loss, congenital cochlear abnormalities or cochlear ossification.

Sponsors & Collaborators

• Wahba bakhet: lead
• Bahteem Specialized Hospital: collaborator

Study Sites (1)

Ainshams University

Cairo, 80010, Egypt

Location

MeSH Terms

Interventions

Lidocaine; Epinephrine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• wahba Z Bakhet, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, Ain shams university

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 26, 2018
• Study Start: August 1, 2014
• Primary Completion: August 26, 2016
• Study Completion: August 26, 2016
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

EG (1)