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ID
Source
Brief title
Health condition
Postoperative nausea and vomiting, PONV, children, ambulatory surgery
Postoperatieve misselijkheid en braken, kinderen, pediatrische patiënten
Sponsors and support
Salud Sura, centro de cirurgia ambulatoria
Carrera 48 # 26-5
Medellin, Antioquia, Colombia
00575144480
Intervention
Outcome measures
Primary outcome
- Nausea
- Vomiting
Secondary outcome
- Pain
- Agitation
Background summary
Postoperative nausea and vomiting (PONV) continues to be a serious complication in children after surgery and the PONV-rate can be as high as 70% in high-risk patients without prophylaxis. The aim of this interventional study is a head-to-head comparison of various anti-emetic drugs that may help to develop a systematic review of pharmacological alternatives for PONV in children. The patients will be stratified based on the amount of risk factors and they will be randomly assigned to a treatment with dexamethasone alone, dexamethasone + a bolus of proposal or dexamethassone + ondansetron. Our primary outcomes are nausea and vomiting. Our secondary outcomes are pain and agitation. Rebleeding and other complications will be carefully monitored.
Study objective
- The incidence of PONV will be higher in the group receiving dexamethasone alone
- There will be no significant difference in the incidence of PONV between the two groups receiving two anti-emetic drugs
- There will be less postoperative agitation in the group receiving propofol
Study design
- 30 minutes after the surgery
- 2 hours after the surgery
- 24 hours after the surgery
Intervention
The patients will be stratified into three groups based on the amount of risk factors for PONV. Then they will be randomly assigned to one of the three treatments:
1. Dexamethasone + placebo
2. Dexamethasone + a bolus of propofol
3. Dexamethasone + ondansetron
Vera-Maria Pavao Spanjer
Groningen
The Netherlands
veraspanjer@hotmail.com
Vera-Maria Pavao Spanjer
Groningen
The Netherlands
veraspanjer@hotmail.com
Inclusion criteria
- Patients aged between 6 months and 12 years
- Patients undergoing ear-nose-throat surgery
- Patients undergoing general anesthesia longer than 30 minutes
Exclusion criteria
- Patients who already attained mernache
- Patients who had used antiemetic's within 24 hours preceding the surgery
- Patients who had used steroids during the previous 3 months preceding the surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL4577 |
| NTR-old | NTR4745 |
| Other | Salud SURA, centro de cirurgia ambulatoria : SURA_25_04_2014 |