Medical premedication in contrast to psychological preparation in children before operation

Medical premedication in contrast to psychological preparation in children - Premediactio study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004895-13-AT

Enrollment

Registered

2012-07-30

Start date

2013-01-30

Completion date

Unknown

Last updated

2026-05-18

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

Conditions

Children who have to undergo a pediatric surgery procedure get preoperative midazolam 1mg/kg but maximum 15mg. It is a common problem, that in children with a weight more than 15 kilos premedication is often useless, because the maximal dose is too low to reach the desired effect. Nevertheless those children are too small to accept the prospective procedure, as mask induction or a venous cannula. Even paradox reactions to benzodiazepines lead to the avoidance of midazolam.

Interventions

Trade Name: Dormicum Product Name: Dormicum Product Code: N05CD08 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Midazolam CAS Number: 59467-70-8 Concentration unit: mg/ml m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Every patient over the age of 2 and under the age of 10 years scheduled for elective ambulant surgery Are the trial subjects under 18? yes Number of subjects for this age range: 50 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: - Patients who are already included into another clinical trial - Parens refusal to participate the study

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is, to explore if a psychological procedure can displace a medical premedication. ;Secondary Objective: no secondary objectives;Primary end point(s): Psychological procedure could replace preoperative medication;Timepoint(s) of evaluation of this end point: Evaluation of anxiety In the preoperative ambulance, directly preoperative, in the afternoon of the operation`s day, on postoperative controll in the ambulance	—

Measure

Time frame

Main Objective: The aim of the study is, to explore if a psychological procedure can displace a medical premedication. ;Secondary Objective: no secondary objectives;Primary end point(s): Psychological procedure could replace preoperative medication;Timepoint(s) of evaluation of this end point: Evaluation of anxiety In the preoperative ambulance, directly preoperative, in the afternoon of the operation`s day, on postoperative controll in the ambulance

—

Secondary

Measure	Time frame
Secondary end point(s): no secondary endpoint;Timepoint(s) of evaluation of this end point: no evaluation	—

Countries

Austria

Contacts

Public ContactPeter Marhofer

Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie

peter.marhofer@meduniwien.ac.at+431404004107

Outcome results

None listed

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