Posttonsillectomy peritonsillar bupivacaine infiltration for pain relief in children.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005467-25-BE

Enrollment

200

Registered

2011-12-08

Start date

2012-01-04

Completion date

Unknown

Last updated

2021-03-30

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

Conditions

postoperative pain treatment MedDRA version: 14.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Contramal Product Name: Contramal Pharmaceutical Form: Injection INN or Proposed INN: TRAMADOL CAS Number: 27203-92-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age between 4 and 10 years ASA I or II Are the trial subjects under 18? yes Number of subjects for this age range: 200 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: having intolerance for or allergic reactions against any product that will be used in the setting lack of parents'written informed consent

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To compare: pain scores bleeding events PONV incidence occurence of complications (upper airway obstruction or vocal cord paralysis);Primary end point(s): Our primary outcome is a reduction of at least 20% of piritramide consumption in the marcain group;Timepoint(s) of evaluation of this end point: at arrival in the recovery room and at 15, 30, 45 and 60minutes after arrival in the recovery room, then every hour untill discharge;Main Objective: To compare the proportion of patients who receive piritramide IV the first six hours after the surgery.	—

Measure

Time frame

Secondary Objective: To compare: pain scores bleeding events PONV incidence occurence of complications (upper airway obstruction or vocal cord paralysis);Primary end point(s): Our primary outcome is a reduction of at least 20% of piritramide consumption in the marcain group;Timepoint(s) of evaluation of this end point: at arrival in the recovery room and at 15, 30, 45 and 60minutes after arrival in the recovery room, then every hour untill discharge;Main Objective: To compare the proportion of patients who receive piritramide IV the first six hours after the surgery.

—

Secondary

Measure	Time frame
Secondary end point(s): A reduction in : Pain scores Bleeding events Incidence of PONV Occurence of complications;Timepoint(s) of evaluation of this end point: at arrival in the recovery room and at 15, 30, 45 and 60minutes after arrival in the recovery room, then every hour untill discharge	—

Countries

Belgium

Contacts

Public ContactAnesthesia Research

University Hospitals Leuven

christel.huygens@uzleuven.be+3216344620

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 22, 2026