Optimal Analgesia in Acute Gastroenteritis

Gastroenteritis Clinical Trial

Official title:

Optimal Analgesia in Acute Gastroenteritis in Emergency Department Setting: Dipyrone Versus Papaverine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02711241
• Other study ID #: AGE123-HMO-CTIL
• Status: Terminated
• Phase: Phase 3
• First received: March 1, 2011
• Last updated: March 13, 2016
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: March 2016
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out an optimal way of analgesia in case of acute infectious gastroenteritis the investigators are going to compare two medicines that are used on everyday basis (without being ever before subject to scientifical study): Dipyrone and papaverine The study is done in the Emergency Department setting. Thus, only first 6 hours of treatment is included in study

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acute gastroenteritis

• VAS scale of pain perception at least 4

Exclusion Criteria:

• pregnancy

• allergy to any one of study preparations

• blood pressure less than 85 on admission

• surgical condition (acute abdomen) suspected or diagnosed

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroenteritis

Intervention

Drug:
• Dipyrone
1 gram by slow IV infusion
• Papaverine
80 mg by slow intravenous infusion

Locations

Country	Name	City	State
Israel	Hadssah Medical Organisation	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain assessment (VAS) as opposed the pain assessment on admission		30 min, 1 hour, 2 hours, on discharge (up to 24 hours)	No
Secondary	Need for second analgesic medicine		24 hours	No