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The effects of peritonsillar infiltration of tramadol versus tramadol plus magnesium on post-tonsillectomy pain - ND

The effects of peritonsillar infiltration of tramadol versus tramadol plus magnesium on post-tonsillectomy pain - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-010064-42-IT
Enrollment
Unknown
Registered
2009-03-06
Start date
2009-02-25
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Tonsillectomy patients MedDRA version: 9.1 Level: LLT Classification code 10053322 Term: Otorhinolaryngological surgery

Interventions

Trade Name: CONTRAMAL Pharmaceutical Form: Solution for infusion INN or Proposed INN: Tramadol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical

Sponsors

AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age older than 14 years, ASA 1-2 (American Society of Anesthesiologists), scheduled for tonsillectomy in Otorhinolaryngoiatric ward Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: Psychiatric, cardiac and renal disease, myasthenia gravis, asthma, oppiod allergy, bleeding trouble in history

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the effect of peritonsillar infiltration of tramadol versus tramadol plus magnesium on the management of post-tonsillectomy pain;Secondary Objective: The effect of infiltration on analgesic consumption;Primary end point(s): The difference between the values of pain NRS in Tramadolo group and the values in tramadol plus magnesium at 15 minutes : ( NRSt ? NRSm )≥ 2.—

Countries

Italy

Outcome results

None listed

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