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.

Investigation of pain syndrome and clinical-biochemical parameters in 7 to 18 years old children with acute uncomplicated appendicitis who received non-surgical treatment.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001400-16-LV

Enrollment

120

Registered

2021-08-06

Start date

2021-07-02

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain syndrome in 7 to 18 years old children with acute uncomplicated appendicitis, who received non-surgical treatment.

Interventions

Trade Name: KETOROLAC-GRINDEKS Pharmaceutical Form: Solution for injection INN or Proposed INN: KETOROLAC TROMETAMOL CAS Number: 74103-07-4 Concentration unit: mg/ml milligram(s)/millilitre Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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; 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;	—

Measure

Time frame

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; 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

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Latvia

Contacts

Public ContactDepartment of Paediatric surgery

Riga Stradins university

jurijs.bormotovs@bkus.lv+37126324310

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026