“Study of pain syndrome and clinical-biochemical parameters in children aged 7 to 18 years in cases of non-surgical treatment of uncomplicated acute appendicitis”

Riga Stradins University1 site in 1 country120 target enrollmentJanuary 30, 2025

DrugsKETOROLAC-GRINDEKS 30 mg/ml šķīdums injekcijām

Overview

Phase: Phase III and phase IV (Integrated)
Intervention: Not specified
Conditions: Not specified
Sponsor: Riga Stradins University
Enrollment: 120
Locations: 1
Primary Endpoint: Number of patients consented from total approached; Number of patients who completed pain assessment and treatment at all time points (totally for 3 days (72 hours));
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To perform a study of pain syndrome and clinical-biochemical parameters in 7 to 18 years old children with uncomplicated acute appendicitis in non-surgical treatment and develop an analgesic algorithm based on the obtained data.

Registry

euclinicaltrials.eu

Start Date

January 30, 2025

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Riga Stradins University

Responsible Party

Principal Investigator

BKUS

Scientific

Riga Stradins University

Eligibility Criteria

Inclusion Criteria

•7 to 18 years old children with first time diagnosed uncomplicated acute appendicitis who received non-surgical treatment.

Exclusion Criteria

•Psychomotor retardation of any degree; Any inherited or acquired immunodeficiency; Any abdominal surgery in medical history; Neurological deficit of any degree; Any endocrine disease; NSAID use within 3 hours; Chronic pain requiring daily analgesic use; History of gastrointestinal bleeding, peptic or duodenal ulcer disease or inflammatory bowel disease, coagulation disorders, prior cerebrovascular bleeding, known arterio-vascular malformations; History of chronic and active renal disease, excluding renal calculi and urinary tract infections; History of chronic and active hepatocellular disease (excludes biliary stones, cholangitis or biliary duct pathology); Known hypersensitivity to ketorolac (or it's component) or other NSAID; Absence of a parent/guardian for children who are < 14 years in age.

Outcomes

Primary Outcomes

Number of patients consented from total approached; Number of patients who completed pain assessment and treatment at all time points (totally for 3 days (72 hours));