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EVALUATION OF A PROTOCOLE FOR ADENOTONSILLECTOMY IN CHILDRE

Conditions
CHILDREN AGED 2 TO 10 YEAR OF AGE SCHEDULED FOR ADENOTONSILLECTOMY IN A ONE DAY HOSPITAL
MedDRA version: 9.1Level: LLTClassification code 10001256Term: Adenotonsillectomy
Registration Number
EUCTR2007-001314-17-BE
Lead Sponsor
ERASME HOSPITA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

CHILDREN AGED 2 TO 10
UNDERGOING ADENOTONSILLECTOMY
ASA CLASSIFICATION I AND II
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

ALLERGY TO TRAMADOL OR PIRITRAMIDE
PATIENT TAKING ANALGESIC DRUG, ANTI-EMETIC DRUG OR CORTICOSTEROIDS BEFORE SURGERY£
RENAL FAILURE
DIABETIS MELLITUS
ANY CARDIAC DISEASE
TRAVEL DISEASE (EMESIS)

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: EVALUATE IF ANALGESIA USING INTRAVENOUS TRAMADOL ALLOWS A QUICKER RELEASE HOME OF THE PATIENT WHEN COMPARED TO ANALGESIA USING INTRAMUSCULAR PIRITRAMIDE;Secondary Objective: ;Primary end point(s): LENGHT OF STAY IN THE POST-ANESTHESIA CARE UNIT
Secondary Outcome Measures
NameTimeMethod
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