Ignite Creation Date:
2024-05-06 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03698565
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2018-09-24
Brief Title:
Evaluation of the Analgesia Nociception Index and Videopupillometry to Predict a Childs Post-tonsillectomy Morphine Prescription
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
Evaluation of the Analgesia Nociception Index and Videopupillometry to Predict a Childs Post-tonsillectomy Morphine Prescription
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENIGME
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None