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Analgesia in acute pediatric abdominal pain

Single-blind randomized controlled trial for acute abdomen analgesia in Pediatric Emergency department - Analgesia in acute pediatric abdominal pain

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-002215-42-IT
Enrollment
300
Registered
2014-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2017-10-02

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

Conditions

Analgesia in pediatric acute abdominal pain MedDRA version: 17.0 Level: PT Classification code 10000081 Term: Abdominal pain System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Tachipirina granulato effervescente bustine Product Name: Acetaminophen Pharmaceutical Form: Oral powder in sachet Trade Name: Tora-Dol Product Name: Ketorolac Pharmaceutical Form: Oral d

Sponsors

IRCCS Burlo Garofolo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children aged 4 to 18 years with acute abdominal pain defined as moderate severe (6-10 VAS or NRS scale) Are the trial subjects under 18? yes Number of subjects for this age range: 300 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: - Assumption of acetaminophen 6 hours or NSAIDs or tramadol 8 hours before entering in the study - protracted diarrhea with weight loss > 5%, refusal to eat or drink, drop in urine output - known liver disease or kidney disease - chronic neurological or metabolic action, - positive history of bleeding or thrombocytopenia - evidence of constipation and execution of barium evacuative

Design outcomes

Primary

MeasureTime frame
Main Objective: The objective of the study is to compare the efficacy and safety of three different treatment regimens based on analgesic drugs administered sublingually most widely used in current clinical practice in Pediatric Emergency Department: paracetamol 20 mg / kg ketorolac 0.5 mg / kg , and tramadol 2 mg / kg.;Secondary Objective: Pain reduction;Primary end point(s): Reduction of pain assessed by VAS or NRS scale at time 0, 30 minutes, 60 minutes and 120 minutes.;Timepoint(s) of evaluation of this end point: From 0 up to 120 minutes—

Secondary

MeasureTime frame
Secondary end point(s): Number of complications in different groups Definition of complications: - Number of missed or delayed diagnosis of acute appendicitis or other abdominal pathology (eg gallstones or pancreatitis) Side-effects: nausea, vomiting, diarrhea, headache, hyper-or hypotension, shrinking diuresis, bleeding ;Timepoint(s) of evaluation of this end point: From 0 up 120 minutes—

Countries

Italy

Contacts

Public ContactAlessandra Maestro

IRCCS Burlo Garofolo

alessandra.maestro@burlo.trieste.it00390403785417

Outcome results

None listed

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