The Effect of Circadian Rhytm on Postoperative Pain Undergoing Pediatric Surgery

How Does Circadian Rhythm Affect Postoperative Pain After Pediatric Acute Appendicit Operation?

These circadian rhythms are self-sustained, endogenous oscillations generated by circadian clocks that persist with a period of around 24 -h under constant conditions. Multiple clinical and foundational science studies report that circadian rhythm disruption can directly alter pain thresholds. Altered circadian pain rhythms manifest inconsistently in various disease states. circadian differences exist in tolerability of administration as well as in effectiveness of analgesia during surgical, obstetric, and dental procedures, with the majority of studies demonstrating highest pain sensitivity during the overnight or early morning hours. Although the relationship between pain states and circadian rhythm has been studied in various surgical procedures and chronic pain syndromes, there is little literature examining the relationship between postoperative pain and circadian rhythm in pediatric surgical procedures. Therefore, it was aimed to evaluate the relationship between postoperative pain and circadian rhythm after pediatric acute appendicitis surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Pain; Circadian Rhythm
• Intervention / Treatment: Other: Group 1, Group 2, Group 3, Group 4

Detailed Description

This study will be conducted with the data to be obtained from the Anesthesiology Surgery Form and Pediatric Surgery Service Forms in 200 patients aged 6-18 years, after the approval of the Faculty Local Ethics Committee in the Department of Anesthesiology, Faculty of Medicine, Selcuk University. According to the time the patients were taken into the operation, Group 1; 01:01-07:00, Group 2; 07:01-13:00, Group 3; 13:01-20:00 and Group 4; 20:01-01:00, It will be divided into four groups between. The files of the patients will be examined and demographic data such as age (year), body weight (kg), height (cm), gender, ASA scores (I-III), anesthesia and surgery time, anesthesia and surgery time will be recorded. Intraoperative vital signs; systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR) oxygen saturation (SpO2) Endtidal CO2 and temperature before operation (control) and 5, 10, 15, 20, 25 and 30 minutes (min) and at the end of the process (end) data will also be saved. Perioperative side effects such as nausea-vomiting, hypotension, bradycardia, tremor, respiratory distress, sore throat, headache, and dizziness symptoms will be noted if they occur. The routinely applied analgesic protocol and vital signs in the postoperative pediatric surgery service, the total amount of analgesic administered, the time to first analgesia requirement and VAS scores at 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded. There will be no interference with the routinely applied analgesic protocol.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42080
    • Selcuk University, School of Medicine
  • Konya, Turkey, 42250
    • Selcuk University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric patient population of both sexes aged 6-18 years

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical condition I-II,
• Undergoing acute appendicitis,
• Patients aged 6-18 years

Exclusion Criteria:

• ASA ≥ III,
• Uncontrolled chronic, metabolic disease,
• Opioid or analgesic use in the last 10 days,
• Acute peritonitis or sepsis
• History of abnormal operation or recovery from anesthesia,
• Patients with parents who are unwilling to give informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Sociodemographic and clinical data of the patients who will be operated between 01:01-07:00 AM will be recorded. The total amount of antiemetic, the time of first antiemetic use, and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded.	Other: Group 1, Group 2, Group 3, Group 4; The total amount of antiemetic,the time of first antiemetic use and VAS scores at 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours postoperatively will also be recorded according to circadian rhythm
Group 2; Patients who were operated between 07:01-13:00. Sociodemographic and clinical data of the patients who will be operated between 07:00 AM- 01:00 PM will be recorded. The total amount of antiemetic, the time of first antiemetic use, and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded.	Other: Group 1, Group 2, Group 3, Group 4; The total amount of antiemetic,the time of first antiemetic use and VAS scores at 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours postoperatively will also be recorded according to circadian rhythm
Group 3; Sociodemographic and clinical data of the patients who will be operated between 01:00 - 08:00 PM will be recorded. The total amount of antiemetic, the time of first antiemetic use and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded.	Other: Group 1, Group 2, Group 3, Group 4; The total amount of antiemetic,the time of first antiemetic use and VAS scores at 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours postoperatively will also be recorded according to circadian rhythm
Group 4; Sociodemographic and clinical data of the patients who will be operated between 08:00 PM -01:00 AM will be recorded. The total amount of antiemetic,the time of first antiemetic use, and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded.	Other: Group 1, Group 2, Group 3, Group 4; The total amount of antiemetic,the time of first antiemetic use and VAS scores at 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours postoperatively will also be recorded according to circadian rhythm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The postoperative VAS pain scores	The VAS scores at 1st will be recorded.	1st hours , postoperatively
The postoperative VAS pain scores	The VAS scores at 2nd will be recorded.	2nd hours , postoperatively
The postoperative VAS pain scores	The VAS scores at 3th will be recorded.	3th hours , postoperatively
The postoperative VAS pain scores	The VAS scores at 6th will be recorded.	6th hours , postoperatively
The postoperative VAS pain scores	The VAS scores at 9th will be recorded.	9th hours , postoperatively
The postoperative VAS pain scores	The VAS scores at 12th will be recorded.	12th hours , postoperatively
The postoperative VAS pain scores	The VAS scores at 15th will be recorded.	15th hours , postoperatively
The postoperative VAS pain scores	The VAS scores at 18th will be recorded.	18th hours , postoperatively
The postoperative VAS pain scores	The VAS scores at 21th will be recorded.	21th hours , postoperatively
The postoperative VAS pain scores	The VAS scores at 24th will be recorded.	24th hours , postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total amount of analgesic	The total amount of analgesic will be recorded postoperativly .	24 hours, postoperatively
the time to first analgesia requirement	the time to first analgesia requirement will be recorded postoperativly .	24 hours, postoperatively

Collaborators and Investigators

• Sponsor: Faruk Cicekci

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): August 15, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: farukcicekci5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: I do not have a plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No