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Children's mood/anxiety, pain, nausea and behavioral changes after premedication with Clonidine versus Midazolam in Ear Nose Throat day surgery.

Children's mood/anxiety, pain, nausea and behavioral changes after premedication with Clonidine versus Midazolam in ENT day surgery. - KloMid

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-005215-42-SE
Enrollment
Unknown
Registered
2013-01-24
Start date
2013-04-12
Completion date
Unknown
Last updated
2013-09-30

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

Conditions

Preanesthetic Medication at ear-nose-throat surgery

Interventions

Trade Name: Klonidinhydroklordid APL Product Name: Klonidinhydroklorid APL Pharmaceutical Form: Oral solution INN or Proposed INN: CLONIDINE HYDROCHLORIDE Other descriptive name: CLONIDINE HYDROCHLOR

Sponsors

Department of Anesthesiology and Intensive Care Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Ear-Nose and Throat day surgery Children 2-7 years of age ASA (American Society of Anaesthesiologists Score) I-II Are the trial subjects under 18? yes Number of subjects for this age range: 130 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: Children not taken Preanesthetic Medication Acute surgery Children or guardians not speaking or understanding Swedish

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess children's behavioral changes after premedication with Clonidine versus Midazolam using PHBQ (Post Hospital Behavior Questionnaire);Secondary Objective: To assess children's mood/anxiety, pain and nausea, with different questionnaires and scales, after premedication with Clonidine versus Midazolam, and what impact on children’s behaviours they give;Primary end point(s): Assessment by PHBQ (Post Hospital Behavior Questionnaire) ;Timepoint(s) of evaluation of this end point: One week after surgery—

Secondary

MeasureTime frame
Secondary end point(s): Assessment with: BTS (Childerns paitings at hospital) m-YPAS (The modified Yale Preoperative Anxiety Scale) FAS (Facial Affektive Scale) FLACC (Face Legs Activity, Cry and Consolability scale). FPS-R Face Pain Scale-Revised PHBQ (Post Hospital Behavior Questionnaire) ;Timepoint(s) of evaluation of this end point: At the postsurgey ward Before discharge from hospital One month after surgery Six month after surgery—

Countries

Sweden

Contacts

Public ContactLars Hedlund

Department of Anesthesiology and Intensive Care Medicine

lars.hedlund@vll.se+46910771380

Outcome results

None listed

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