DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

Information source: IRCCS Burlo Garofolo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine

Intervention: metoclopramide (Drug); placebo (Drug); ketoprofen (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: IRCCS Burlo Garofolo

Official(s) and/or principal investigator(s):
Edoardo Guglia, MD, Principal Investigator, Affiliation: IRCCS Burlo Garofolo

Overall contact:
Edoardo Guglia, MD, Phone: +390403785373, Email: edigugl@gmail.com

Summary

This is a Randomized double blind trial with the aim to estimate the effectiveness of 3 therapeutic regimes per os on migraine pain:

- metoclopramide 0,15 mg/kg + placebo

- metoclopramide 0,15 mg/Kg + ketoprofen 1 mg/kg

- ketoprofen 1 mg/Kg + placebo

Intensity of pain will be measured with linear 1-10 scale or analogic McGrath type scale every 20 min. The main objective is the evaluation of healing times from pain in the 3 groups

Clinical Details

Official title: Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: evaluation of healing times from pain in the 3 groups

Secondary outcome:

comparison of percentage of healing from acute migraine and of relapses of pain in the three arms of trial

need of a rescue drug for lack of effect in every arms of the trial

Eligibility

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Children 6-17 years old with migraine presenting in emergency room

Exclusion Criteria:

- Informed consensus not obtained

- Occurring migraine still treated

- Hemiplegic migraine

Locations and Contacts

Edoardo Guglia, MD, Phone: +390403785373, Email: edigugl@gmail.com

Edoardo Guglia, Trieste 34100, Italy; Not yet recruiting
angela De Cunto, MD, Phone: +390403785333, Email: angela.decunto@libero.it
Patrizia Salierno, MD, Phone: +390403785373, Email: patty76@aliceposta.it
Additional Information

Starting date: February 2009
Last updated: January 28, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017