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Does the Newborn Infant Parasympathetic Evaluation (NIPE) Index Predict Postsurgical Pain in Children

Post Operative Pain

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 timely and objective manner, thereby improving patient safety, parental satisfaction, and reducing healthcare costs. We think that, validating the utility of NIPE in children under 3 years of age will allow the implementation of a novel pain assessment tool to our current practice of anesthetic care. This will improve the perioperative pain management, in particular for patients who are unable to communicate pain, with the potential to reduce detrimental consequences of postoperative pain.

And also determining the relationship between the NIPE scores and validated FLACC scale for post-operative pain and PAED scale during the recovery from anesthesia and also to determine whether NIPE values at extubation correlates with the incidence of moderate and/or severe pain in PACU.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    3 to 7

Participation Criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Study Location

Montreal Children's Hospital
Montreal Children's Hospital
Montréal, Quebec
Canada

Contact Study Team

Backup Contact

Gianluca Bertolizio

[email protected]
Primary Contact

Gianluca Bertolizio, MD

[email protected]
Study Sponsored By
McGill University Health Centre/Research Institute of the McGill University Health Centre
Participants Required
More Information
Study ID: NCT04909060