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PainNoLPedFentaNCT04786275

Evaluation of the Nociception Guided by NoL Index and PK of Fentanyl in Pediatric Patients Under General Anesthesia

An observational study of Pain and Anesthesia, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Fentanyl is one of the most common used opioids for analgesia during general anesthesia, however there are few studies that describe the relationship between its pharmacokinetics and pharmacodynamics, especially in the pediatric population. Read more about this study

Who is it for?
Ages 3 to 10 years
Conditions the study is for
Pain, Anesthesia, Pediatric ALL
What is being tested?
Fentanyl and Tetanic stimulation
How many people
25 participants
Where
1 siteChile
Study dates
1 Dec 2020to 31 Mar 2023
Phase
Observational
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 3 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: ASA I or II children from 3 up to 10 years requiring elective non-cardiac surgery, under general anesthesia and caudal block.

Who may be able to join

  • Children 3-10 years old
  • ASA I - II
  • Lower abdominal or urological surgery, requiring general anesthesia and caudal block

Who cannot join

  • Obese patients
  • ASA III - IV - V
  • Allergy to fentanyl
  • Emergency surgery
  • Patients with sleep apnea
  • Surgeries anticipated to have an increased volume exchange or transfusion

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Pontificia Universidad Catolica de Chile

    Santiago, Santiago Metropolitan

Other trials in Chile

About this study

Official title: Evaluation of the Nociception Guided by NoL Index and Pharmacokinetics of Fentanyl in Pediatric Patients Under General Anesthesia for Non-cardiac Elective Surgery

Fentanyl is one of the most common used opioids for analgesia during general anesthesia, however there are few studies that describe the relationship between its pharmacokinetics and pharmacodynamics, especially in the pediatric population. The monitoring of the analgesia component during general anesthesia has been traditionally by changes in patient's vital signs, with new devices that measure nociceptive indexes like the Nociception level (NoL) index currently being validated for adults. There is still lacking evidence with nociceptive indexes in the pediatric population.

Insufficient dose of opioids may cause sympathetic response, respiratory complications, development of persistent post-surgical pain and even prolonged hospitalization. In the other hand, and overdose of opioids may cause over sedation, postoperatory nausea and vomiting, respiratory depression, hyperalgesia and tolerance.

Given the lack of evidence on the Pharmacokinetic and pharmacodynamic (PK/PD) of fentanyl in this group of patients, has led to raise the development of this observational prospective study; which is to describe a PK/PD model of fentanyl in pediatric population, through evaluation of the NoL index, in patients submitted to elective general non-cardiac surgery.

Read the detailed description

Patients will be invited to participate before surgery, the inclusion criteria will be revised and the informed consent will be signed by one of the parents or legal tutor.

In the operating room will be recorded demographic data and relevant background such as: Age, Weight, Size, BMI.

Afterwards, in the operating room, the patient will be monitored regularly: EKG, pulse oximetry, non invasive blood pressure.

Induction of anesthesia with sevoflurane 6% in 100% oxygen, once loss of consciousness, 2 peripheral IV lines will be installed, one for medication and the other in the contralateral arm for blood samples. After that, a laryngeal mask device (LMA) appropriate for the weight for the management of the airway. In addition, the EEG will be monitored through a frontal electroencephalographic monitoring (BIS) system and a NoL index sensor, both of which will be recorded throughout the surgery.

Once all monitors are installed, a caudal block with 0,5-1 ml of bupivacaine 0,25% will be performed, in the left decubitus lateral position. Ventilator and vaporizer adjustments for an EtCO2 of 35-40 mmHg and a BIS index of 50-60 with Sevoflurane. After 12 minutes, because of the latency of caudal block; surgeons may start. If an effective caudal block is proven, the study will continue; if there is movement of the child, laryngospasm or an increase of more than 10% in the base values of heart rate or blood pressure, the patient will be excluded from the study.

Standardized nociceptive stimulus will be administered through a tetanic stimulus (70 Hz, 80 mA) for 5 seconds in the forearm. An initial tetanic stimulus will be performed, 2 minutes afterwards a unique dose of fentanyl of 2 micrograms per kg will be administered. New tetanic stimulus will be applied at 5, 15, 30 and 45 minutes after the fentanyl dose and blood samples for fentanyl plasmatic levels will be taken at the same time in the operating room and at 75 or 120 minutes in the post anesthesia care unit (PACU). NoL index values will be recorded after each tetanic stimulus.

After surgery, sevoflurane will be discontinued, LMA removed and the patients transferred to the PACU. Pain scores will be evaluated in the PACU using Visual analogue scale. Analgesic management with NSAIDs and Acetaminophen.

PK/PD profile of fentanyl will be evaluated with NONMEM (non-linear mixed effects modelling) software for the analysis.

Being tested
Fentanyl, Tetanic stimulation
Keywords
NoL, Nociception level, Fentanyl, Pediatric anesthesia, Pharmacokinetics
Medical subject headings
Pain, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FentanylDrug

    Standard dose of 2 ug/kg after tetanic stimulation.

  • Tetanic stimulationOther

    Standard tetanic stimulation will be used as the stimulus to evaluate response of the intraoperative pain index (NoL) at a standard fentanyl dose.

Study groups in NCT04786275
Study groupRoleWhat they receive
Tetanic stimulationSingle arm study
Receives: Drug: Fentanyl; Other: Tetanic stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NoL index.

    Variations in the NoL index (0-100). NoL has a range from 0-100, with 0 indicates no pain and 100 indicates worst pain. Data will also be analyzed using nonlinear mixed effect modeling (NONMEM)

    Measured: Since induction of anesthesia until emergence of anesthesia (one hour in average)

  2. Change of the plasmatic levels of fentanyl

    Describe the change of the levels of fentanyl plasmatic levels (ng/mL) measured by high pressure liquid chromatography (HPLC).

    Measured: 5, 15, 30, 45, 75 until 120 minutes after one dose of fentanyl.

  3. Peak Plasma Concentration (Cmax)

    Calculate maximum plasma concentration (Cmax) fentanyl plasma levels measured with high pressure fluid (HPLC) after a single bolus of fentanyl in enrolled pediatric patients.

    Measured: 5, 15, 30, 45, 75 until 120 minutes after one dose of fentanyl.

Secondary outcomes (5)

  1. Hemodynamics

    Arterial pressure (mmHg)

    Measured: At time of surgery, up to 120 minutes.

  2. Heart rate (bpm)

    Heart rate (bpm)

    Measured: At time of surgery, up to 120 minutes

  3. Pulse oximetry

    % oximetry saturation

    Measured: At time of surgery, up to 120 minutes.

  4. Bispectral index

    Depth of anesthesia will be recorded with BIS monitor

    Measured: At time of surgery, up to 120 minutes

  5. Pain in Visual analogue scale (0-10)

    Postoperative pain will be evaluated with Visual analogue scale (0-10), being a score of 10 worst outcome, in the PACU for 120 minutes immediately after surgery.

    Measured: Every 15 minutes in the PACU, up to 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2021
  2. Study start1 Dec 2020
  3. Primary completion31 Dec 2022
  4. Study completion31 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04786275
Sponsor's protocol ID
190416008
Acronym
NoLPedFenta
Status last verified
Nov 2023
First submitted
27 Jan 2021
Last updated
27 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Analysis plan

Publications

  • Ziesenitz VC, Vaughns JD, Koch G, Mikus G, van den Anker JN. Pharmacokinetics of Fentanyl and Its Derivatives in Children: A Comprehensive Review. Clin Pharmacokinet. 2018 Feb;57(2):125-149. doi: 10.1007/s40262-017-0569-6.

    PubMed 28688027

  • Lotsch J. Pharmacokinetic-pharmacodynamic modeling of opioids. J Pain Symptom Manage. 2005 May;29(5 Suppl):S90-103. doi: 10.1016/j.jpainsymman.2005.01.012.

    PubMed 15907650

  • Renaud-Roy E, Stockle PA, Maximos S, Brulotte V, Sideris L, Dube P, Drolet P, Tanoubi I, Issa R, Verdonck O, Fortier LP, Richebe P. Correlation between incremental remifentanil doses and the Nociception Level (NOL) index response after intraoperative noxious stimuli. Can J Anaesth. 2019 Sep;66(9):1049-1061. doi: 10.1007/s12630-019-01372-1. Epub 2019 Apr 17.

    PubMed 30997633

Questions about this trial

What is this clinical trial studying?

An observational study of Pain and Anesthesia, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

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 6 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 27 Nov 2023. 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 Chile. 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. 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?

NoL index. (time frame: Since induction of anesthesia until emergence of anesthesia (one hour in average)). The study lists 3 primary outcomes in all. 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 NCT04786275, which also lists 3 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 27 Nov 2023.

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