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

NCT04909060 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2023-05-03

No results posted yet for this study

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

Interventions

DEVICE

noninvasive blood pressure, 3 lead ECG, peripheral oxygen saturation

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

Sponsors & Collaborators

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

    lead OTHER

Eligibility

Min Age
3 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04909060 on ClinicalTrials.gov