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

NCT03698565 | Completed

• 1 other identifier: 87RC17_0109 (ENIGME)
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Pain Postoperative; Tonsillectomy; Analgesia Nociception Index; Pupillary Index Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 0 (End of the surgery)

• 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.

  Day 0 (End of the surgery)

Secondary Outcomes (3)

• Correlation between Analgesia Nociception Index measured and maximum score obtained at FLACC scale

  Day 1 (Leaving the Post-interventional Monitoring Room)

• Correlation between Pain Pupillary Index measured and maximum score obtained at FLACC scale

  Day 1 (Leaving the Post-interventional Monitoring Room)

• Correlation between variation of the pupillary diameter measured and maximum score obtained at FLACC scale

  Day 1 (Leaving the Post-interventional Monitoring Room)

Study Arms (1)

PPI and ANI measurements

EXPERIMENTAL

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.

Other: Nerve stimulation of the ulnar nerve

Interventions

Nerve stimulation of the ulnar nerve OTHER

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.

PPI and ANI measurements

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

University Hospital

Limoges, 87042, France

Location

Related Publications (1)

• Evrard B, Lefebvre C, Spiry P, Hodler C, Chapellas C, Youssef B, Gauthier F, Marais L, Labrunie A, Douchez M, Senges P, Cros J, Nathan-Denizot N. Evaluation of the Analgesia Nociception Index and videopupillometry to predict post-tonsillectomy morphine requirements in children: a single-centre, prospective interventional study. BJA Open. 2022 Jul 31;3:100024. doi: 10.1016/j.bjao.2022.100024. eCollection 2022 Sep.

  PMID: 37588574 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Charles HODLER, PH

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 9, 2018
• Study Start: December 20, 2018
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

FR (1)