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OpenTrials
Completed

NCT Number: NCT03854604

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

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.

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Key information

Conditions

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

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Abeer Ahmed, Cairo, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

postoperative pain assessment

Other

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

Primary outcomes

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

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Perfusion Index as an Objective Measure for Postoperative Pain Assessment in Pediatric Patients Undergoing Adenotonsillectomy. An Observational Study.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2019
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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