ACTRN12609000387224
Completed
未知
A randomised controlled trial to assess respiratory complications following removal of a laryngeal mask (awake vs. anaesthetised) in children undergoing adeno-/tonsillectomy with a high risk of postoperative respiratory complications
Britta von Ungern-Sternberg0 sites290 target enrollmentStarted: May 29, 2009Last updated:
Overview
- Phase
- 未知
- Status
- Completed
- Sponsor
- Britta von Ungern-Sternberg
- Enrollment
- 290
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- o limit to 16 Years (—)
- Sex
- All
Inclusion Criteria
- •Children, aged 0 to 16 years, male or female undergoing elective adenoidectomy or adenotonsillectomies with or without grommets insertion with one or more of the following risk factors (I\-III) with the plan to use a laryngeal mask airway (as assessed by an anaesthetist independent of the study team):
- •I.Airway susceptibility as defined as 1 or more of the following
- •a.Cold or flu in the last two weeks
- •b.Wheezing \> 3 times in the last 12 months
- •c.Wheezing at exercise
- •d.Nocturnal dry cough
- •II.Current or past eczema
- •III.Positive family history as defined as 1 or more of the following
- •a.\=2 family members with asthma
- •b.\=2 family members with eczema
Exclusion Criteria
- •Known cardiac disease, airway or thoracic malformations, need for premedication with midazolam.
Investigators
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