Post Operative PainNCT05758090
Newborn Infant Parasympathetic Evaluation (NIPE) for Guiding Intraoperative Fentanyl in Children Under 2 Years
A study testing NIPE monitor in people with Post Operative Pain and Analgesia, run by Khon Kaen University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Post Operative Pain, Analgesia, Children, Only
- What is being tested?
- NIPE monitor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- 10 Mar 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn up to 2 years old
- ASA Status 1-2
- Undergoing elective surgery of upper part of body
Who cannot join
- Premature
- Arrhythmia
- Concomitant use of regional anesthesia
- Plan for ICU admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Newborn Infant Parasympathetic Evaluation (NIPE) Index Versus Standard Hemodynamic Response for Guiding Intraoperative Fentanyl Administration in Children Younger Than 2 Years Under General Anesthesia
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.
Read the 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.
- Conditions
- Post Operative Pain, Analgesia, Children, Only, Narcotic Use
- Being tested
- NIPE monitor, Control
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPE monitorProcedure or surgery
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.
ControlProcedure or surgery
Procedure/Surgery: Standard protocol. Give intraoperative fentanyl according to vital signs.
| Study group | Role | What they receive |
|---|---|---|
| Group NIPE | Experimental | Intraoperative fentanyl administration will be guided by NIPE protocol Receives: Procedure: NIPE monitor |
| Group Control | Placebo comparator | Intraoperative fentanyl administration will be guided by clinical signs Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain: Face, Legs, Activity, Cry, Consolability scale (FLACC scale)
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.
Measured: During 120 minutes in PACU
Secondary outcomes (2)
Postoperative fentanyl consumption
Fentanyl administration in PACU
Measured: During 120 minutes in PACU
Postoperative sedation score
Sedation score (0-3; higher scores mean a worse outcome) in PACU
Measured: During 120 minutes in PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start10 Mar 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thepakorn Sathitkarnmanee, Khon Kaen University
- Investigators
- Sirirat Tribuddharat, MD, PhD, Study chair, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758090
- Sponsor's protocol ID
- HE651243
- Status last verified
- Apr 2024
- First submitted
- 23 Feb 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weber F, Roeleveld HG, Geerts NJE, Warmenhoven AT, Schroder R, de Leeuw TG. The heart rate variability-derived Newborn Infant Parasympathetic Evaluation (NIPE) Index in pediatric surgical patients from 0 to 2 years under sevoflurane anesthesia-A prospective observational pilot study. Paediatr Anaesth. 2019 Apr;29(4):377-384. doi: 10.1111/pan.13613. Epub 2019 Mar 21.
PubMed 30793426Recher M, Boukhris MR, Jeanne M, Storme L, Leteurtre S, Sabourdin N, De Jonckheere J. The newborn infant parasympathetic evaluation in pediatric and neonatology: a literature review. J Clin Monit Comput. 2021 Oct;35(5):959-966. doi: 10.1007/s10877-021-00670-8. Epub 2021 Feb 15.
PubMed 33590418Lim BG. Nociception monitoring tools using autonomic tone changes for intraoperative analgesic guidance in pediatric patients. Anesth Pain Med (Seoul). 2019 Oct 31;14(4):380-392. doi: 10.17085/apm.2019.14.4.380.
PubMed 33329766Zhang K, Wang S, Wu L, Song Y, Cai M, Zhang M, Zheng J. Newborn infant parasympathetic evaluation (NIPE) as a predictor of hemodynamic response in children younger than 2 years under general anesthesia: an observational pilot study. BMC Anesthesiol. 2019 Jun 11;19(1):98. doi: 10.1186/s12871-019-0774-y.
PubMed 31185928
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Newborn Infant Parasympathetic Evaluation (NIPE) Index Versus Standard Hemodynamic Response for Guiding Intraoperative Fentanyl Administration in Children Younger Than 2 Years Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05758090
- Acronym / sponsor ID
- HE651243
- Conditions
- Post Operative Pain, Analgesia, Children, Only, Narcotic Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group NIPE | Experimental | Procedure: NIPE monitorIntraoperative fentanyl administration will be guided by NIPE protocol |
| Group Control | Placebo comparator | Procedure: ControlIntraoperative fentanyl administration will be guided by clinical signs |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborn up to 2 years old
- ASA Status 1-2
- Undergoing elective surgery of upper part of body
Key exclusion criteria (4 listed)
- Premature
- Arrhythmia
- Concomitant use of regional anesthesia
- Plan for ICU admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIPE monitorProcedure/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. | Procedure or surgery | Group NIPE |
| ControlProcedure/Surgery: Standard protocol. Give intraoperative fentanyl according to vital signs. | Procedure or surgery | Group Control |
Primary outcome
Postoperative pain: Face, Legs, Activity, Cry, Consolability scale (FLACC scale)
Time frame: 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.
2 secondary outcomes
Postoperative fentanyl consumption
Time frame: During 120 minutes in PACU
Postoperative sedation score
Time frame: During 120 minutes in PACU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Results publication: PubMed 30793426Weber F, Roeleveld HG, Geerts NJE, Warmenhoven AT, Schroder R, de Leeuw TG. The heart rate variability-derived Newborn Infant Parasympathetic Evaluation (NIPE) Index in pediatric surgical patients from 0 to 2 years under sevoflurane anesthesia-A prospective observational pilot study. Paediatr Anaesth. 2019 Apr;29(4):377-384. doi: 10.1111/pan.13613. Epub 2019 Mar 21.
- Results publication: PubMed 33590418Recher M, Boukhris MR, Jeanne M, Storme L, Leteurtre S, Sabourdin N, De Jonckheere J. The newborn infant parasympathetic evaluation in pediatric and neonatology: a literature review. J Clin Monit Comput. 2021 Oct;35(5):959-966. doi: 10.1007/s10877-021-00670-8. Epub 2021 Feb 15.
- Results publication: PubMed 33329766Lim BG. Nociception monitoring tools using autonomic tone changes for intraoperative analgesic guidance in pediatric patients. Anesth Pain Med (Seoul). 2019 Oct 31;14(4):380-392. doi: 10.17085/apm.2019.14.4.380.
- Results publication: PubMed 31185928Zhang K, Wang S, Wu L, Song Y, Cai M, Zhang M, Zheng J. Newborn infant parasympathetic evaluation (NIPE) as a predictor of hemodynamic response in children younger than 2 years under general anesthesia: an observational pilot study. BMC Anesthesiol. 2019 Jun 11;19(1):98. doi: 10.1186/s12871-019-0774-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirirat Tribuddharat, MD, PhD study chair
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIPE monitor in people with Post Operative Pain and Analgesia, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain: Face, Legs, Activity, Cry, Consolability scale (FLACC scale) (time frame: During 120 minutes in PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05758090, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.