To assess whether a single shot of dexamethasone reduces postoperative pain, and reduces the time children need to start with drinking and eating.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
keelaandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain will be assessed by:
- Comfort scores
- Cheops scores
- Visual analog scale (vas) from the nurses and the parents
Drinking and eating behavior will be assessed by:
- The quality of life questionnaire
- Time children need to drink 100 cc
- Time children need to start eating food
Secondary outcome
children who receive a single shot dexamethasone together with paracetamol and
diclofenac, will they start drinking and eating faster after operation
Background summary
(Adeno) tonsillectomy is a very painful procedure. Many children complain about
pain for several days. Besides drinking and eating is often very problematic.
In a Cochrane analyses is was shown that administration of dexamethasone
reduced nausea and vomiting and lead to faster drinking and eating behavior in
children after undergoing (A)TE. We presume that this improved drinking and an
improved pain relief causes eating behavior. However, data about this are
lacking.
If the study will show, that postoperative pain and morbidity decrease, we will
change our protocol, so all children, undergoing tonsillectomy will get a
single shot of dexamethasone preoperative.
Study objective
To assess whether a single shot of dexamethasone reduces postoperative pain,
and reduces the time children need to start with drinking and eating.
Study design
A double blind randomized study, where 112 children in age from 3 - 7 years old
are included who are undergoing tonsillectomy. Children are randomized to
either a single shot dexamethasone or to a placebo. Both will be given directly
after anesthetic induction.
Postoperative pain, and drinking and eating behavior will be assessed by
validated measures, starting at the anesthetic recovery room, at day care every
hour and at home at day 2 and 7.
Intervention
Administration of a single bolus dose of dexamethasone or placebo, directly
after anesthetic induction.
Study burden and risks
According to a Cochrane review, dexamethasone can be safely administered in
children undergoing (A)TE.
Children will receive the same care as children. On the contrary, parents are
asked to fill in some questionnaires; normally they are not asked to fill in
questionnaires
Dr. Molenwaterplein 60
3015 GJ
Nederland
Dr. Molenwaterplein 60
3015 GJ
Nederland
Listed location countries
Age
Inclusion criteria
age: 3 till 7 years old
asa class 1 or 2 by the American Society of Anesthesiologists
informed consent by the parents
Exclusion criteria
mental retardation
abnormal renal function
hepatic diseas
bloodclumping problems
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 47609651 |
| EudraCT | EUCTR2007-001170-92-NL |
| CCMO | NL16787.078.07 |