Perfusion Index as an Objective Measure for Postoperative Pain Assessment in Pediatric Patients.

NCT03854604 | Completed DMC

• 1 other identifier: N-110-2018
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

It has been demonstrated that infants and children experience pain in a similar manner to adults, however it used to be undertreated when compared to adult. Perfusion Index (PI) derived from pulse plethysmography waveform, represents a ratio of pulsatile signal (during arterial inflow) to non-pulsatile signal. PI can represent the peripheral perfusion dynamics due to change of peripheral vasomotor tone. Low PI values suggest peripheral vasoconstriction and high PI values suggest peripheral vasodilation. The sympathetic nervous system is inherently involved in the pathophysiological responses evoked by painful stimulation. In the current study, investigators hypothesise that the PI could be a good objective tool for assessment of postoperative pain in children undergoing adenotonsillectomy.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Correlation between postoperative (Children's Hospital of Eastern Ontario Scale ) CHEOPS score and postoperative perfusion index.

  the time span between arrival to PACU and for at least two hours postoperative

Secondary Outcomes (1)

• validity of perfusion index to predict postoperative pain and the need of rescue analgesia

  he time span between arrival to PACU and for at least two hours postoperative

Interventions

postoperative pain assessment OTHER

evaluation of the efficacy of PI as an objective measure for postoperative pain assessment in pediatric population undergoing adenotonsillectomy.

Eligibility Criteria

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

Study Population

Children 3-7 years, ASA physical status I or II, undergoing Adenotonsillectomy will be included

You may qualify if:

• ASA physical status I-II
• Age 3 to 7 years
• Children undergoing adenotonsillectomy.

You may not qualify if:

• Parents' refusal.
• Children with behavioral changes
• Children with physical developmental delay
• Children on treatment with sedative or anticonvulsant.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (3)

Abeer Ahmed

Cairo, 002211, Egypt

Location

Kasr Alainy Faculty of Medicine - Cairo university

Cairo, 00225, Egypt

Location

Anesthesia department - Faculty of medicine- Cairo University

Cairo, Egypt

Location

Related Publications (1)

• Ahmed A, Lotfy A, Elkholy J, Abdelhamid B, Ollaek M. Perfusion index as an objective measure of postoperative pain in children undergoing adenotonsillectomy: a cohort study. J Clin Monit Comput. 2022 Jun;36(3):795-801. doi: 10.1007/s10877-021-00710-3. Epub 2021 Apr 23.

  PMID: 33891250 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia, SICU & pain management. Kasralainy Faculty of medicine

Study Record Dates

• First Submitted: February 16, 2019
• First Posted: February 26, 2019
• Study Start: March 20, 2019
• Primary Completion: June 20, 2019
• Study Completion: September 20, 2019
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

EG (3)