Clinical trial • Gastroenterology

KETOROLAC TROMETAMOL for Uncomplicated acute appendicitis

Clinical trial of KETOROLAC TROMETAMOL for Uncomplicated acute appendicitis. 120 participants.

Overview

Clinical trial across 1 site in Latvia.

Recruits 120 paediatric patients.

Vulnerable Population: Participants are children aged 7 to 18 years (vulnerable population selected). The protocol excludes absence of a parent/guardian for children who are < 14 years in age. A subject information and informed consent form document is listed (indicating consent procedures are provided); specific assent language or multiple-language details are not provided in the record.

{"criterion_text":"- 7 to 18 years old children with first time diagnosed uncomplicated acute appendicitis who received non-surgical treatment."}

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

{"endpoint_text":"- Number of patients consented from total approached\n- Number of patients who completed pain assessment and treatment at all time points (totally for 3 days (72 hours));","definition_or_measurement_approach":"Counts of patients: (1) number consented from total approached; (2) number who completed pain assessment and treatment at all time points over a total period of 3 days (72 hours)."}

Planned Sample Size: 120
Recruitment Window Months: 77
Consent Approach: Informed consent is indicated via a listed subject information and informed consent form document. Participants are minors (7-18 years); the protocol excludes children lacking a parent/guardian for those <14 years, indicating parental/guardian consent is required for younger children. Specific assent procedures, languages, or age-stratified consent documents are not detailed in the provided record.

Investigational Product Name: KETOROLAC-GRINDEKS 30 mg/ml šķīdums injekcijām
Active Substance: KETOROLAC TROMETAMOL
Modality: Small molecule
Routes Of Administration: SOLUTION FOR INJECTION
Route: SOLUTION FOR INJECTION
Authorisation Status: Marketing authorisation (marketingAuthNumber: 07-0240, authorisationCountryCode: LV)
Maximum Dose: 90 mg

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