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EVALUATION OF A PROTOCOLE FOR ADENOTONSILLECTOMY IN CHILDREN

EVALUATION OF A PROTOCOLE FOR ADENOTONSILLECTOMY IN CHILDREN

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-001314-17-BE
Enrollment
Unknown
Registered
2007-05-07
Start date
2007-07-10
Completion date
Unknown
Last updated
2013-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHILDREN AGED 2 TO 10 YEAR OF AGE SCHEDULED FOR ADENOTONSILLECTOMY IN A ONE DAY HOSPITAL MedDRA version: 9.1 Level: LLT Classification code 10001256 Term: Adenotonsillectomy

Interventions

Trade Name: DOLZAM Pharmaceutical Form: Intravenous infusion Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use Trade Name: DIPIDOLOR Pha

Sponsors

ERASME HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026