Status:
UNKNOWN
Does the Newborn Infant Parasympathetic Evaluation (NIPE) Index Predict Postsurgical Pain in Children
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Post Operative Pain
Eligibility:
All Genders
3-7 years
Brief Summary
An investigation to find out if Newborn Infant Parasympathetic Evaluation (NIPE) index predicts postsurgical pain in children, since NIPE is thought to may be of guide to the appropriate therapy in a ...
Detailed Description
Pain represents a sensorial experience in response to tissue damage, that does not only affects the emotional and functional domains of an individual, but also leads to multiple detrimental, unanticip...
Eligibility Criteria
Inclusion
- Children between 3 and 7 years old, scheduled for elective adeno-tonsillectomy, tonsillectomy or adenoidectomy.
- Only patients whose parents are fluent in French or English will be enrolled
Exclusion
- Patients with neurological or cardiac congenital deficits, with cardiac arrythmias (non-sinus rhythm)
- Implanted pacemakers, with a history of prolonged resuscitation at birth, on chronic therapy with drugs that have known effects on sympathetic and parasympathetic activity (antimuscarinics, beta 2 adrenergic agonists
- Alpha 1-adrenergic antagonists or antiarrhythmic agents,
- Tricyclic antidepressants.
- ASA physical status III or higher and parent/guardian refusal.
- Patients be scheduled for surgery without an appointment at the Montreal Children's Hospital (MCH) Preoperative Clinic
- A surgery appointment within 24 hours of surgery, will not be enrolled into the study.
- As this study will be conducted with only one NIPE monitor, and it will be devoted to the patient for about 1.5 hours, two consecutive patients cannot be enrolled in the study. In this case, the second patient will be considered eligible but excluded, and data will not be collected.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04909060
Start Date
September 1 2021
End Date
December 1 2024
Last Update
May 3 2023
Active Locations (1)
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1
Montreal Children's Hospital
Montreal, Quebec, Canada, H3C4C9