Analgesia in acute pediatric abdominal pai

Phase 1

• Conditions: Analgesia in pediatric acute abdominal pain; MedDRA version: 17.0Level: PTClassification code 10000081Term: Abdominal painSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-002215-42-IT
• Lead Sponsor: IRCCS Burlo Garofolo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-03
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 300

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

- 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

Study & Design

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