Analgesia, Children, Only, Narcotic Use, Post Operative Pain
Conditions
Brief summary
During general anesthesia, objective monitoring for analgesia is still lacking. The administration of opioids relies on the experience of the anesthesiologist. There are some monitors, e.g., Analgesia Nociception Index (ANI), showing that they can evaluate analgesia in adults. Recently, a Newborn Infant Parasympathetic Evaluation (NIPE) monitor was released for assessing analgesia in children with age less than 2 years. The investigators aim to assess the efficacy of NIPE as a guide for intraoperative fentanyl administration in children under 2 years.
Detailed description
During balanced anesthesia, hypnosis can be monitored with BIS, muscle relaxation can be monitored with a train-of-four, however, analgesia lacks precise monitoring. The anesthesiologist administers narcotics according to clinical signs and experience. Analgesia Nociception Index (ANI) has been introduced as an objective monitor for analgesia in adults. Recently, a Newborn Infant Parasympathetic Evaluation (NIPE) monitor has been introduced to assess analgesia in children under 2 years, however, clinical studies regarding its clinical efficacy are scarce. The objective of this study is to assess the efficacy of NIPE as a guide for intraoperative fentanyl administration in children under 2 years.
Interventions
PROCEDURENIPE monitor
Procedure/Surgery: NIPE protocol. Give intraoperative fentanyl according to NIPE value. NIPE score 50-70 indicates optimal narcotic effect. NIPE score \> 70 indicated overdosage of narcotic and narcotic should be withheld. NIPE score \< 50 indicates inadequate narcotic and narcotic should be given.
PROCEDUREControl
Procedure/Surgery: Standard protocol. Give intraoperative fentanyl according to vital signs.
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 2 Years
Healthy volunteers
No
Inclusion criteria
* Newborn up to 2 years old * ASA Status 1-2 * Undergoing elective surgery of upper part of body
Exclusion criteria
* Premature * Arrhythmia * Concomitant use of regional anesthesia * Plan for ICU admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain: Face, Legs, Activity, Cry, Consolability scale (FLACC scale) | During 120 minutes in PACU | Assess pain using a FLACC score every 15 minutes. FLACC has a range from 0 to 10 with 0 indicates no pain while 10 indicates worst pain. NRS of 0-3 is mild, 4-6 is moderate, and 7-10 is severe pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative fentanyl consumption | During 120 minutes in PACU | Fentanyl administration in PACU |
| Postoperative sedation score | During 120 minutes in PACU | Sedation score (0-3; higher scores mean a worse outcome) in PACU |
Countries
Thailand
Outcome results
None listed