Acute Migraine in childhood MedDRA version: 9.1 Level: LLT Classification code 10027599 Term: Migraine
Conditions
Interventions
Product Name: Metoclopramide
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: Metoclopramide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration num
Sponsors
ISTITUTO PER L'INFANZIA BURLO GAROFOLO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: After obtainance of informed consensus from legal tutors of child, all the children between 6 and 17 years with cephalea responding to migraine criteria (see attached) and presenting in Emergency room in the next two years, will be enrolled, with a extimation of 120 patients at the end of the study. Are the trial subjects under 18? yes Number of subjects for this age range: 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: Occuring migraine still treated. Informed consensus not obtained. Emiplegic migraine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Evaluation of failures and necessity of rescue treatment after 2 hours and after 24 hours.;Primary end point(s): Comparison of remission time of acute migraine among the three arms of the study.;Main Objective: This is a randomized double blind trial with the aim to estimate the effectiveness of 3 therapeutic regimes per os on migraine pain: a) metoclopramide 0,15 mg/kg + placebo b) metoclopramide 0,15 mg/kg + ketoprofene 1 mg/kg c) placebo + ketoprofene 1 mg/kg. Intensity of pain will be measured with lineare 1-10 scale or analogic McGrath type scale every 20 min. The main objective is the evaluation of healing times from the pain in the 3 groups. | — |
Countries
Italy
Outcome results
None listed