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Evaluation of the Analgesia Nociception Index and Videopupillometry to Predict a Child's Post-tonsillectomy Morphine Prescription (ENIGME)

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nerve stimulation of the ulnar nerve
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Postoperative focused on measuring Pain Postoperative, Tonsillectomy, Analgesia Nociception Index, Pupillary Index Pain

Eligibility Criteria

undefined - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any child for whom tonsillectomy is programmed ≥ 2 years and up to 7 years inclusive
  • Consent written and signed by at least one holder of exercise of parental authority

Exclusion Criteria:

  • Eye disease
  • Cardiac pathology
  • Neurological pathology
  • Chronic opioid treatment
  • Any treatment interfering with the autonomic nervous system
  • Any contraindication to NSAIDs

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PPI and ANI measurements

Arm Description

The intervention is the nerve stimulation of the ulnar nerve for evaluation / realization of PPI by videopupillometry. The realization of PPI and ANI measurements is carried out at the end of the surgical procedure, it implies a maintenance of the anesthesia for approximately 5 additional minutes.

Outcomes

Primary Outcome Measures

Prognostic value of the Pupillary Index Pain ® measured at the end of the surgical intervention
Presence or absence of a morphine prescription during the SSPI.
Prognostic value of the average Analgesia Nociception Index measured at the end of the surgical intervention
Presence or absence of a morphine prescription during the SSPI.

Secondary Outcome Measures

Correlation between Analgesia Nociception Index measured and maximum score obtained at FLACC scale
The correlation coefficient of Pearson or Spearman between the Analgesia Nociception Index measured by the PhysioDoloris® monitor at the end of the surgical intervention and the maximum score obtained at the FLACC scale during the stay in the Post-interventional Monitoring Room.
Correlation between Pain Pupillary Index measured and maximum score obtained at FLACC scale
The correlation coefficient of Pearson or Spearman between the Pupillary Index ® Pain measured by Algiscan at the end of the surgical intervention and the maximum score obtained at the FLACC scale during the stay in the Post-interventional Monitoring Room.
Correlation between variation of the pupillary diameter measured and maximum score obtained at FLACC scale
The correlation coefficient of Pearson or Spearman between the change in pupillary diameter measured by Algiscan® at the end of the surgical intervention and the maximum score obtained at the FLACC scale during the stay in the Post-interventional Monitoring Room.

Full Information

First Posted
September 24, 2018
Last Updated
December 2, 2020
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT03698565
Brief Title
Evaluation of the Analgesia Nociception Index and Videopupillometry to Predict a Child's Post-tonsillectomy Morphine Prescription
Acronym
ENIGME
Official Title
Evaluation of the Analgesia Nociception Index and Videopupillometry to Predict a Child's Post-tonsillectomy Morphine Prescription
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
February 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Some surgeries, such as tonsillectomies, are particularly painful postoperatively because they are not very accessible to a complementary technique of loco-regional anesthesia and require the use of opioids in the postoperative period. The use of opioids, in combination with usual analgesics, is common after this surgery. However, some risks are associated with the use of morphine in children, including more frequent respiratory distress, nausea and vomiting, and can cause hemorrhagic complications and lengthen the duration of hospitalization. Decreasing the consumption of morphine drugs is therefore a real challenge. Although there is no randomized controlled study on the use of standard analgesics with or without morphine to date, a number of studies suggest that the use of morphine should not be systematic after a surgery. The need for opioids after tonsillectomy as well as the level of pain vary between patients. Some teams use morphine at the end of general anesthesia to prevent pain on waking and others use it only if needed, once the child is awake. Pain assessment scales are used in the Post-interventional Monitoring Room (PIMR) to adapt these analgesic therapies according to the intensity of pain. One of the validated and frequently used scales in pediatric PIMR is FLACC (Face Legs Activity Cry Consolability). Monitoring tools are also available to evaluate the quality of intraoperative analgesia in unconscious children : the analysis of the pupillary variation in response to a painful stimulus by videopupillometry, and the ANI (Analgesia Nociception Index) which consists of estimating the sympathetic-parasympathetic balance by a complex analysis of cardiac rhythm variability. These two types of monitoring could predict which children will require post-operative morphine treatment. To date, no study has demonstrated the relationship between videopupillometry and postoperative morphine consumption. The average ANI has already been evaluated in children as correlated with FLACC but both monitoring devices have never been compared for a predictive purpose. The investigators hypothesize that the use of the PPI® (Pain Pupillary Index) scale of Algiscan® and the average ANI measured by the PhysioDoloris® monitor in children still sedated at the end of the intervention could have a prognostic value on post-operative morphine prescription.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Pain Postoperative, Tonsillectomy, Analgesia Nociception Index, Pupillary Index Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PPI and ANI measurements
Arm Type
Experimental
Arm Description
The intervention is the nerve stimulation of the ulnar nerve for evaluation / realization of PPI by videopupillometry. The realization of PPI and ANI measurements is carried out at the end of the surgical procedure, it implies a maintenance of the anesthesia for approximately 5 additional minutes.
Intervention Type
Other
Intervention Name(s)
Nerve stimulation of the ulnar nerve
Intervention Description
The intervention is the nerve stimulation of the ulnar nerve for evaluation / realization of PPI by videopupillometry. The realization of PPI and ANI measurements is carried out at the end of the surgical procedure, it implies a maintenance of the anesthesia for approximately 5 additional minutes.
Primary Outcome Measure Information:
Title
Prognostic value of the Pupillary Index Pain ® measured at the end of the surgical intervention
Description
Presence or absence of a morphine prescription during the SSPI.
Time Frame
Day 0 (End of the surgery)
Title
Prognostic value of the average Analgesia Nociception Index measured at the end of the surgical intervention
Description
Presence or absence of a morphine prescription during the SSPI.
Time Frame
Day 0 (End of the surgery)
Secondary Outcome Measure Information:
Title
Correlation between Analgesia Nociception Index measured and maximum score obtained at FLACC scale
Description
The correlation coefficient of Pearson or Spearman between the Analgesia Nociception Index measured by the PhysioDoloris® monitor at the end of the surgical intervention and the maximum score obtained at the FLACC scale during the stay in the Post-interventional Monitoring Room.
Time Frame
Day 1 (Leaving the Post-interventional Monitoring Room)
Title
Correlation between Pain Pupillary Index measured and maximum score obtained at FLACC scale
Description
The correlation coefficient of Pearson or Spearman between the Pupillary Index ® Pain measured by Algiscan at the end of the surgical intervention and the maximum score obtained at the FLACC scale during the stay in the Post-interventional Monitoring Room.
Time Frame
Day 1 (Leaving the Post-interventional Monitoring Room)
Title
Correlation between variation of the pupillary diameter measured and maximum score obtained at FLACC scale
Description
The correlation coefficient of Pearson or Spearman between the change in pupillary diameter measured by Algiscan® at the end of the surgical intervention and the maximum score obtained at the FLACC scale during the stay in the Post-interventional Monitoring Room.
Time Frame
Day 1 (Leaving the Post-interventional Monitoring Room)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any child for whom tonsillectomy is programmed ≥ 2 years and up to 7 years inclusive Consent written and signed by at least one holder of exercise of parental authority Exclusion Criteria: Eye disease Cardiac pathology Neurological pathology Chronic opioid treatment Any treatment interfering with the autonomic nervous system Any contraindication to NSAIDs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles HODLER, PH
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France

12. IPD Sharing Statement

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Evaluation of the Analgesia Nociception Index and Videopupillometry to Predict a Child's Post-tonsillectomy Morphine Prescription

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