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van CCT (UK)

van CCT (UK)

Prophylactic treatment for postoperative nausea and vomiting in children undergoing ambulatory surgery

- candidate number17593
- NTR NumberNTR4745
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-apr-2014
- Secondary IDsSURA_25_04_2014 Salud SURA, centro de cirurgia ambulatoria
- Public TitleProphylactic treatment for postoperative nausea and vomiting in children undergoing ambulatory surgery
- Scientific TitleEffectiveness of dexamethasone combined with propofol vs dexamethasone combined with ondansetron vs dexamethasone alone as a postoperative nausea and vomiting prophylaxis in pediatric patients undergoing ambulatory surgery: a randomized blinded trial
- ACRONYMProphylaxis in PONV in children
- hypothesis- 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
- Healt Condition(s) or Problem(s) studiedPostoperative nausea and vomiting (PONV), Children
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-apr-2014
- planned closingdate30-aug-2014
- Target number of participants90
- InterventionsThe 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
- Primary outcome- Nausea
- Vomiting
- Secondary outcome- Pain
- Agitation
- Timepoints- 30 minutes after the surgery
- 2 hours after the surgery
- 24 hours after the surgery
- Trial web site
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIES Vera-Maria Pavao Spanjer
- Sponsor/Initiator Salud Sura, centro de cirurgia ambulatoria Colombia
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryPostoperative 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.
- Main changes (audit trail)
- RECORD28-apr-2014 - 12-sep-2014

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