The Effect of Circadian Rhytm on Postoperative Pain Undergoing Pediatric Surgery

NCT05379192 | Unknown

• 1 other identifier: farukcicekci5
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Circadian Rhythm; Postoperative Pain

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (2)

• The total amount of analgesic

  24 hours, postoperatively

• the time to first analgesia requirement

  24 hours, postoperatively

Study Arms (4)

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

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

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

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

Interventions

Group 1, Group 2, Group 3, Group 4 OTHER

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 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 6 Years - 18 Years
• Gender Eligibility Details: Postoperative pain differs in both sexes according to the circadian rhythm.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric patient population of both sexes aged 6-18 years

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faruk Cicekci: lead

Study Sites (2)

Selcuk University, School of Medicine

Konya, 42080, Turkey (Türkiye)

Location

Selcuk University, School of Medicine

Konya, 42250, Turkey (Türkiye)

Location

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: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Prof.

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 18, 2022
• Study Start: January 1, 2022
• Primary Completion: August 15, 2022
• Study Completion: December 31, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)