Recruiting

Observational Study

Sponsor:

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

Code:

NCT04909060

Conditions

Post Operative Pain

Eligibility Criteria

Sex: All

Age: 3 - 7

Healthy Volunteers: Not accepted

Interventions

noninvasive blood pressure, 3 lead ECG, peripheral oxygen saturation

Study Details

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

Study ID

NCT04909060

Start date

Sep 1, 2021

Status verified date

May, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 7

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

  • Validation of NIPE as a tool to prevent and assess postoperative pain will improve monitoring of children and potentially their outcome [ Time Frame: 24 Hours ]

Central Contacts and Locations

Central contacts

Gianluca Bertolizio, MD,FRCPC

514586-2674gianluca.bertolizo@mcgill.ca

Sara Chisling, MD

5146290260sara.chisling@mcgill.ca

Locations

Montreal Children's Hospital

Recruiting

Montréal, Quebec, Canada, H3C4C9

Contacts

Gianluca Bertolizio, MD

gianluca.bertolizio@mcgill.ca

Gianluca Bertolizio

gianluca.bertolizio@mcgill.ca

More Information

Sponsor

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

Last update posted

May 3, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2023-05-03.