- 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…
ID
Bron
Verkorte titel
Aandoening
Postoperative nausea and vomiting, PONV, children, ambulatory surgery
Postoperatieve misselijkheid en braken, kinderen, pediatrische patiënten
Ondersteuning
Salud Sura, centro de cirurgia ambulatoria
Carrera 48 # 26-5
Medellin, Antioquia, Colombia
00575144480
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Nausea<br>
- Vomiting
Achtergrond van het onderzoek
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.
Doel van het onderzoek
- 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
Onderzoeksopzet
- 30 minutes after the surgery
- 2 hours after the surgery
- 24 hours after the surgery
Onderzoeksproduct en/of interventie
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
Algemeen / deelnemers
Vera-Maria Pavao Spanjer
Groningen
The Netherlands
veraspanjer@hotmail.com
Wetenschappers
Vera-Maria Pavao Spanjer
Groningen
The Netherlands
veraspanjer@hotmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Patients aged between 6 months and 12 years
- Patients undergoing ear-nose-throat surgery
- Patients undergoing general anesthesia longer than 30 minutes
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL4577 |
NTR-old | NTR4745 |
Ander register | Salud SURA, centro de cirurgia ambulatoria : SURA_25_04_2014 |