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

NCT04909060 | Unknown DMC

• 1 other identifier: Observational
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Validation of NIPE as a tool to prevent and assess postoperative pain will improve monitoring of children and potentially their outcome

  24 Hours

Interventions

noninvasive blood pressure, 3 lead ECG, peripheral oxygen saturation DEVICE

Children between 1 and 3 years old, scheduled for elective adeno-tonsillectomy, tonsillectomy or adenoidectomy and with no neurological or cardiac congenital deficits, no cardiac arrythmias (non-sinus rhythm), no implanted pacemakers, nor with a history of prolonged resuscitation at birth, and chronic therapy with drugs that have known effects on sympathetic and parasympathetic activity, ASA physical status III or higher and parent/guardian refusal will have a NIPE placed on their electrocardiogram, at least 20 minutes before the expected end of the surgery, the NIPE monitor will be connected to the anesthesia monitor at the end of the surgery, when the patient is considered ready to be transferred to the PACU, the NIPE will be disconnected and reconnected to the patient monitor once in PACU. Values will be recorded until the patient meets the discharge criteria from PACU not before 2hours

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preschool children

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal Children's Hospital

Montreal, Quebec, H3C4C9, Canada

RECRUITING

Related Publications (1)

• Chisling S, Jette E, Engelhardt T, Ingelmo P, Poulin-Harnois C, Garbin M, Wasserman S, Bertolizio G. Does heart rate variability using the Newborn Infant Parasympathetic Evaluation index identify postsurgical pain levels and emergence delirium in toddlers? A prospective observational study. Can J Anaesth. 2024 Aug;71(8):1117-1125. doi: 10.1007/s12630-024-02764-8. Epub 2024 May 8.

  PMID: 38720113 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Gianluca Bertolizio, MD,FRCPC

CONTACT

514586-2674; gianluca.bertolizo@mcgill.ca

Sara Chisling, MD

CONTACT

5146290260; sara.chisling@mcgill.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCPC, Associate Professor, Anesthesiologist

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-05

Locations

CA (1)