Study of pain level and signs of inflammation connection in 7 to 18 years old children with uncomplicated acute appendicitis, who were treated without surgical operation.

Phase 1

• Conditions: Pain syndrome in 7 to 18 years old children with acute uncomplicated appendicitis, who received non-surgical treatment.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2021-001400-16-LV
• Lead Sponsor: Riga Stradins university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-06
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

7 to 18 years old children with first time diagnosed uncomplicated acute appendicitis who received non-surgical treatment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): Number of patients consented from total approached;<br>Number of patients who completed pain assessment and treatment at all time points (totally for 3 days (72 hours));;Timepoint(s) of evaluation of this end point: Day 1-3: in-patient treatment;

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Not applicable;Secondary end point(s): Not applicable