Pain and Discomfort After Appendectomy in Children

NCT03791229 | Unknown

• 1 other identifier: SAU14113
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Appendectomy is the most common surgical procedure. Chronic abdominal pain is an uncommon complication following appendectomy. It is observed that pediatric patients who have undergone abdominal surgical procedure complained of pain and discomfort in the postoperative period and these complaints may affect quality of life. We aimed to investigate the presence of postoperative chronic abdominal pain and discomfort in children aged 8-18 years underwent appendectomy and their social and physical effects. The records of children aged 8-18 years who underwent appendectomy, such as age, gender, American Society of Anesthesiology (ASA) classification score, the type of surgical procedure, and anesthetic technique were obtained. Children had inclusions crietrias, pain was assessed using numerical rating scale and their effects on life were assessed Pediatric Quality of Life Inventory parent and child versions questionnaire at sixth months after surgery.

Conditions

Appendicitis; Chronic Post-Procedural Pain

Keywords

Appendectomy; Chronic abdominal pain; Discomfort; Numerical rating scale; Pediatric quality of life inventory

Outcome Measures

Primary Outcomes (1)

• Prevalence of chronic pain

  The primary endpoint of this study is to investigate the prevalence of chronic pain and discomfort. Chronic pain is going to be assessed using numeric rating scale (NRS). The NRS for pain is a unidimensional measure of pain intensity in adults and children. The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "nopain") and 10 representing the other pain extreme (e.g.,"pain as bad as you can imagine" and "worst pain imag-inable"). 0 point represents "no pain", 1-3 "mild pain", 4-6 "moderate pain", 7-10 "severe pain".

  at the 6th month after appendectomy in pediatric patients

Secondary Outcomes (1)

• the effects of chronic pain on quality of life

  at the 6th month after appendectomy in pediatric patients

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children aged 8-18 years who underwent appendectomy

You may qualify if:

• Children between the ages of 8-18 years who underwent appendectomy,
• who had ASA I physical score
• who agree to participate for this research

You may not qualify if:

• Children who aged under 8 and over 18 years,
• who had ASA II and those with higher physical score,
• who had previously undergone surgery from the right lower abdomen,
• who had preoperative pain complaint over 6 month,
• who had psychiatric disorders,
• who do not agree to participate

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University School of Medicine Department of Anesthesiology

Sakarya, Adapazari, 54100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Onur Palabiyik, MD

  Sakarya University School of Medicine, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Medical Doctor

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: January 2, 2019
• Study Start: May 1, 2018
• Primary Completion: March 31, 2019
• Study Completion: April 30, 2019
• Last Updated: January 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)