The Effect of Circadian Rhytm on Postoperative Pain Undergoing Pediatric Surgery

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05379192
• Other study ID #: farukcicekci5
• Status: Active, not recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Circadian Rhythm
• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Selcuk University, School of Medicine	Konya
Turkey	Selcuk University, School of Medicine	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Faruk Cicekci

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The postoperative VAS pain scores	The VAS scores at 1st will be recorded.	1st hours , postoperatively
Primary	The postoperative VAS pain scores	The VAS scores at 2nd will be recorded.	2nd hours , postoperatively
Primary	The postoperative VAS pain scores	The VAS scores at 3th will be recorded.	3th hours , postoperatively
Primary	The postoperative VAS pain scores	The VAS scores at 6th will be recorded.	6th hours , postoperatively
Primary	The postoperative VAS pain scores	The VAS scores at 9th will be recorded.	9th hours , postoperatively
Primary	The postoperative VAS pain scores	The VAS scores at 12th will be recorded.	12th hours , postoperatively
Primary	The postoperative VAS pain scores	The VAS scores at 15th will be recorded.	15th hours , postoperatively
Primary	The postoperative VAS pain scores	The VAS scores at 18th will be recorded.	18th hours , postoperatively
Primary	The postoperative VAS pain scores	The VAS scores at 21th will be recorded.	21th hours , postoperatively
Primary	The postoperative VAS pain scores	The VAS scores at 24th will be recorded.	24th hours , postoperatively
Secondary	The total amount of analgesic	The total amount of analgesic will be recorded postoperativly .	24 hours, postoperatively
Secondary	the time to first analgesia requirement	the time to first analgesia requirement will be recorded postoperativly .	24 hours, postoperatively