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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03854604
• Other study ID #: N-110-2018
• Status: Completed
• Start date: March 20, 2019
• Est. completion date: September 20, 2019

Study information

• Verified date: August 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 20, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

1. ASA physical status I-II

2. Age 3 to 7 years

3. Children undergoing adenotonsillectomy.

Exclusion Criteria:

1. Parents' refusal.

2. Children with behavioral changes

3. Children with physical developmental delay

4. Children on treatment with sedative or anticonvulsant.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Egypt	Abeer Ahmed	Cairo
Egypt	Anesthesia department - Faculty of medicine- Cairo University	Cairo
Egypt	Kasr Alainy Faculty of Medicine - Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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