Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment

Phase 4

Completed

• Conditions: Renal Colic
• Interventions: Drug: Paracetamol+Morphine; Drug: Dexketoprofen plus Morphine; Drug: Placebo plus Morphine

• Registration Number: NCT03865004
• Lead Sponsor: Akdeniz University

Brief Summary

This randomized, placebo-controlled trial evaluated the analgesic efficacy and safety of intravenous morphine-paracetamol combination and morphine-dexketoprofen combination morphine for the optimum treatment of renal colic. Combination of IV morphine and paracetamol is as effective and rapid as combination of IV Morphine and IV dexketoprophen for optimum treating of renal colic.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-17
• Primary Completion: 2016-10-17
• Study Completion: 2018-10-17
• Status Verified: 2019-03
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-05
• Last Update Submitted: 2019-03-05
• Study First Posted: 2019-03-06
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Renal colic patients -

Exclusion Criteria

Not renal colic patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo plus Morphine	-
Paracetamol	Paracetamol+Morphine	-
Paracetamol	Dexketoprofen plus Morphine	-
Paracetamol	Placebo plus Morphine	-
Dexketoprofene	Paracetamol+Morphine	-
Dexketoprofene	Placebo plus Morphine	-
Placebo	Paracetamol+Morphine	-
Placebo	Dexketoprofen plus Morphine	-
Dexketoprofene	Dexketoprofen plus Morphine	-

Primary Outcome Measures

Name	Time	Method
pain reductions in VAS scores during the 60th and 90th minutes	60 minutes

Secondary Outcome Measures

Name	Time	Method
Need for rescue analgesic	30 minutes