Comparison of Analgesia Nociception Index (ANI) guided opioid administration on postoperative pain score, opioid requirement and stress response in children undergoing cochlear implant surgery

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/09/036412
• Lead Sponsor: AIIMS New Delhi

Brief Summary

The assessment of pain in children for safe, optimal and effective analgesia is a challenging task. Advances in analgesia monitoring may manage pain objectively in children. Opioid administration based on hemodynamics and clinical signs may lead to under dosage or over dosage and result in side effects like intraoperative movement, postoperative pain, postoperative nausea and vomiting, and respiratory depression. Recent studies suggested that ANI is more sensitive to detect surgical stimuli during surgery and useful for monitoring intraoperative analgesia than the other hemodynamic parameters.Thus, we hypothesise that in comparison to hemodynamic parameters guided perioperative opioid administration, ANI guided management will result in favourable pain scores postoperatively, less increase in surgery-related stress hormones and decrease in the incidence of emergence delirium in children undergoing cochlear implant surgery. After preanaesthesia check up and obtaining consent, child will be shifted to operation theatre on the day of surgery. After noting baseline hemodynamic parameters, general anaesthesia will be administered in both the groups. In the control group, IV fentanyl 1mcg/kg will be administered when HR and/or BP is more than 20 percent of baseline and repeated until it reaches baseline. In the ANI group, IV fentanyl 1mcg/kg will be administered when mean ANI >50 and repeated every 5 minutes until it is <50. Blood samples will be collected before and at the end of surgery. The child will be monitored in post anaesthesia care unit for 90 minutes. During those 90min, we will record the FLACC scores, amount of fentanyl administered, incidence of emergence delirium using the PAED scale, and other side effects like nausea and vomiting, shivering and respiratory depression every 10 minutes. If the PAED score is more than10, IV midazolam 0.1mg/kg will be administered. Children will be discharged when the Modified Aldrete Score reaches more than 9.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-09
• Study Completion: 2022-03-10
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1.ASA 1 and 2 2.Scheduled for elective cochlear implant.

Exclusion Criteria

1.Severe cardiac/respiratory disease 2.Parental refusal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether use of Analgesia Nociception Index (ANI) guided perioperative opioid administration results in decrease in FLACC scale score postoperatively	from the start of surgery to upto 90 minutes in post anaesthesia care unit

Secondary Outcome Measures

Name	Time	Method
To compare ANI-guided vs hemodynamic parameter guided opioid administration on:	1.Total fentanyl consumption

Trial Locations

Locations (1)

AIIMS, New Delhi; 🇮🇳 Delhi, DELHI, India

AIIMS, New Delhi

🇮🇳Delhi, DELHI, India

Rajeshwari Subramaniam

Principal investigator

9810079229

drsrajeshwari@gmail.com