Pain, PostoperativeENIGMENCT03698565
Evaluation of the Analgesia Nociception Index and Videopupillometry to Predict a Child's Post-tonsillectomy Morphine Prescription
A study testing Nerve stimulation of the ulnar nerve in people with Pain, Postoperative, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Nerve stimulation of the ulnar nerve
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2018to 10 Feb 2020
- 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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Eye disease
- Cardiac pathology
- Neurological pathology
- Chronic opioid treatment
- Any treatment interfering with the autonomic nervous system
- Any contraindication to NSAIDs
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Nerve stimulation of the ulnar nerve
- Keywords
- Pain Postoperative, Tonsillectomy, Analgesia Nociception Index, Pupillary Index Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve stimulation of the ulnar nerveOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nerve stimulation of the ulnar nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0 (End of the surgery)
Secondary outcomes (3)
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.
Measured: Day 1 (Leaving 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.
Measured: Day 1 (Leaving 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.
Measured: Day 1 (Leaving the Post-interventional Monitoring Room)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start20 Dec 2018
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles HODLER, PH, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698565
- Sponsor's protocol ID
- 87RC17_0109 (ENIGME)
- Acronym
- ENIGME
- Status last verified
- Jul 2025
- First submitted
- 24 Sep 2018
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37588574
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesia Nociception Index and Videopupillometry to Predict a Child's Post-tonsillectomy Morphine Prescription
- ClinicalTrials.gov ID
- NCT03698565
- Acronym / sponsor ID
- ENIGME / 87RC17_0109 (ENIGME)
- Conditions
- Pain, Postoperative
- Keywords
- Pain Postoperative, Tonsillectomy, Analgesia Nociception Index, Pupillary Index Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 9 Oct 2018 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPI and ANI measurements | Experimental | Other: Nerve stimulation of the ulnar nerveThe 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. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- Eye disease
- Cardiac pathology
- Neurological pathology
- Chronic opioid treatment
- Any treatment interfering with the autonomic nervous system
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 |
|---|---|---|
| Nerve stimulation of the ulnar nerveThe 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 | PPI and ANI measurements |
Primary outcome
Prognostic value of the Pupillary Index Pain ® measured at the end of the surgical intervention
Time frame: Day 0 (End of the surgery)
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
Time frame: Day 0 (End of the surgery)
Presence or absence of a morphine prescription during the SSPI.
3 secondary outcomes
Correlation between Analgesia Nociception Index measured and maximum score obtained at FLACC scale
Time frame: Day 1 (Leaving the Post-interventional Monitoring Room)
Correlation between Pain Pupillary Index measured and maximum score obtained at FLACC scale
Time frame: Day 1 (Leaving the Post-interventional Monitoring Room)
Correlation between variation of the pupillary diameter measured and maximum score obtained at FLACC scale
Time frame: Day 1 (Leaving the Post-interventional Monitoring Room)
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 30 Jul 2025.
- Results publication: PubMed 37588574Evrard 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.
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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.
Charles HODLER, PH principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve stimulation of the ulnar nerve in people with Pain, Postoperative, run by University Hospital, Limoges at 1 site in France.
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 2 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 30 Jul 2025. 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 France. 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?
Prognostic value of the Pupillary Index Pain ® measured at the end of the surgical intervention (time frame: Day 0 (End of the surgery)). The study lists 2 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 NCT03698565, which also lists 1 linked publication.
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 30 Jul 2025.