Phase 4
Completed N=379
Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?
Psychomotor Agitation
Source: ClinicalTrials.gov NCT02361476 ↗
Enrolled (actual)
379
Serious AEs
1.1%
Results posted
Feb 2019
Primary outcomePrimary: Postoperative Agitation — 46; 86 participants with agitation
Summary
Clonidine is widely used off-label in children for several indications. Clonidine is used for treatment and/or prevention of postoperative agitation in children anaesthetised with Sevoflurane. The investigators don´t have solid evidence for the effect and the investigators don´t have data for characterization of the pharmacokinetic profile among age-groups for children 1-6 years.
In this study the investigators want to investigate if IV Clonidine administered at the end of surgery can prevent/reduce postoperative agitation. Secondary outcomes include measurements of postoperative pain relief and adverse effects, including a 30-day follow-up.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Agitation |
46; 86 | — |
| SECONDARY Fentanyl and Morphine Requirements |
0.46; 0.7 | — |
| SECONDARY Pain Assessment |
1.57; 2.45 | — |
| SECONDARY First Administration of Fentanyl or Morphine |
105; 60 | — |
| SECONDARY Adverse Events |
0; 5; 2; 2; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- scheduled for surgery with Sevoflurane as the choice of anesthesia.
Exclusion Criteria
- ASA classification >2
- Premedication with Clonidine
- Ex-premature (born before week 37+0 AND 50 kg.
- Allergy to Clonidine.
- Patients treated with methylphenidate / Concerta.
Data sourced from ClinicalTrials.gov (NCT02361476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.