Effects of a reduced dose of tramadol intravenous, in association with paracetamol, in control of Postoperative Pain after tonsillectomy or adenotonsillectomy in Paediatric population:a clinical, controlled, randomized, single-blind study (TRAPPED study)

Effects of a reduced dose of tramadol intravenous, in association with paracetamol, in control of Postoperative Pain after tonsillectomy or adenotonsillectomy in Paediatric population:a clinical, controlled, randomized, single-blind study (TRAPPED study) - TRAPPED study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001014-28-IT

Enrollment

Registered

2021-06-08

Start date

2017-10-20

Completion date

Unknown

Last updated

2024-03-12

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

Conditions

tonsillectomy or adenotonsillectomy MedDRA version: 20.0 Level: PT Classification code 10001256 Term: Adenotonsillectomy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1 Level: PT Classification code 10044006 Term: Tonsillectomy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: CONTRAMAL - 100 MG/2 ML SOLUZIONE INIETTABILE 5 FIALE 2 ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: TRAMADOLO CLORIDRATO CAS Number: 36282-47-0 Current Sponsor code:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients selected for tonsillectomy or adenotonsillectomy age between 4 - 10, ASA's classification: 1 - 2 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: ASA's classification = > 3 Patients <4 years of age and patients over 10 years patients rundergoing emergency tonsillectomy or adenotonsillectomy

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of the administration of a low dose of tramadol (1mg / kg) in combination with Paracetamol and the onset of side effects in the first 12 hours after surgery;Secondary Objective: Determine the number of patients with postoperative nausea and vomiting within 12 hours of surgery, and the average VAS value (Wong-Baker scale) at 6 hours after surgery.;Primary end point(s):	—

Measure

Time frame

Main Objective: To evaluate the effect of the administration of a low dose of tramadol (1mg / kg) in combination with Paracetamol and the onset of side effects in the first 12 hours after surgery;Secondary Objective: Determine the number of patients with postoperative nausea and vomiting within 12 hours of surgery, and the average VAS value (Wong-Baker scale) at 6 hours after surgery.;Primary end point(s):

—

Countries

Italy

Contacts

Public ContactU.O. Anestesia e Rianimazione 1 del

APSS- Ospedale S. Chiara

massimiliano.detassis@apss.tn.it0461903298

Outcome results

None listed

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