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Completed

NCT Number: NCT03721081

Local Anesthesia for Pediatric Cochlear Implant

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).

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Key information

Conditions

Anesthesia, Local

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ainshams University

Cairo, 80010, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Xylocaine 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.

Primary outcomes

  1. number of patients requiring rescue opioid analgesia (Tramal)

    Time frame: During the length of hospital stay post surgery (on average 24 hours)

    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)

Secondary outcomes

  1. The operative time

    Time frame: Intraoperative

    Minutes

  2. The anesthesia time.

    Time frame: Intraoperative

    Minutes

  3. Heart rate

    Time frame: Intraoperative

    beats per minute

  4. mean arterial blood pressure

    Time frame: Intraoperative

    mm Hg

  5. ESRT responses

    Time frame: Intraoperative

    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

  6. Anesthetic consumption

    Time frame: Intraoperative

    propofol and remifentanil requirement after the bolus

Sponsors and collaborators

Lead sponsor

Wahba bakhet

Other

Collaborators

  • Bahteem Specialized Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 26, 2018
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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