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A study of intravenous amisulpride as prevention of post-operative nausea and vomiting in children
EU CTIS ID: 2024-518778-15-00
What this study is testing
To evaluate the efficacy of IV amisulpride in the prevention of PONV (Prevention of post-operative nausea and vomiting) in pediatric patients.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patients aged from full-term birth (in France, from one month of age) to 17 years of age
- Signed informed consent form and/or assent and willingness of patient and parents to participate in the trial
- Patients undergoing non-emergency surgery, preferentially eye surgery, adenotonsillectomy or otoplasty, under general anesthesia (other than total intravenous anesthesia with propofol) expected to last at least 30 minutes from induction of anesthesia to removal of ETT or LMA
- American Society of Anesthesiologists (ASA) risk score I-III
- For females of child-bearing potential, defined as fertile, following menarche and until becoming post-menopausal (defined as no menses for 12 months without an alternative medical cause; a high follicle stimulating hormone level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy, but in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient) unless permanently sterilized by a reliable method such as hysterectomy, bilateral salpingectomy or bilateral oophorectomy: ability and willingness to use a highly effective form of contraception (as defined in the guideline “Recommendations related to contraception and pregnancy testing in clinical trials”, version 1.1, issued by the Clinical Trials Facilitation and Coordination Group of the Heads of Medicines Agency) between the date of screening and at least 48 hours after administration of study drug: • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o oral o intravaginal o transdermal • progestogen-only hormonal contraception associated with inhibition of ovulation: o oral o injectable o implantable • intrauterine device • intrauterine hormone-releasing system • bilateral tubal occlusion • vasectomized partner (provided that partner is the sole sexual partner of the patient and that the vasectomized partner has received medical assessment of the surgical success) • sexual abstinence.
You likely can't join if
- Patients scheduled to undergo transplant or CNS surgery
- Patients being treated with levodopa
- Patients who are pregnant or breast feeding
- Patients with congenital long QT syndrome, or with factors that predispose to QT prolongation, such as low left ventricular ejection fraction, left ventricular hypertrophy, ischemia, slow heart rate, or electrolyte abnormalities including hypokalemia and hypomagnesemia
- Patients with a tumor of the anterior pituitary
- Patients who have received emetogenic anti-cancer chemotherapy in the previous 4 weeks
See the full eligibility criteria
Who can join
- Male or female patients aged from full-term birth (in France, from one month of age) to 17 years of age
- Signed informed consent form and/or assent and willingness of patient and parents to participate in the trial
- Patients undergoing non-emergency surgery, preferentially eye surgery, adenotonsillectomy or otoplasty, under general anesthesia (other than total intravenous anesthesia with propofol) expected to last at least 30 minutes from induction of anesthesia to removal of ETT or LMA
- American Society of Anesthesiologists (ASA) risk score I-III
- For females of child-bearing potential, defined as fertile, following menarche and until becoming post-menopausal (defined as no menses for 12 months without an alternative medical cause; a high follicle stimulating hormone level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy, but in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient) unless permanently sterilized by a reliable method such as hysterectomy, bilateral salpingectomy or bilateral oophorectomy: ability and willingness to use a highly effective form of contraception (as defined in the guideline “Recommendations related to contraception and pregnancy testing in clinical trials”, version 1.1, issued by the Clinical Trials Facilitation and Coordination Group of the Heads of Medicines Agency) between the date of screening and at least 48 hours after administration of study drug: • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o oral o intravaginal o transdermal • progestogen-only hormonal contraception associated with inhibition of ovulation: o oral o injectable o implantable • intrauterine device • intrauterine hormone-releasing system • bilateral tubal occlusion • vasectomized partner (provided that partner is the sole sexual partner of the patient and that the vasectomized partner has received medical assessment of the surgical success) • sexual abstinence.
What rules you out
- Patients scheduled to undergo transplant or CNS surgery
- Patients being treated with levodopa
- Patients who are pregnant or breast feeding
- Patients with congenital long QT syndrome, or with factors that predispose to QT prolongation, such as low left ventricular ejection fraction, left ventricular hypertrophy, ischemia, slow heart rate, or electrolyte abnormalities including hypokalemia and hypomagnesemia
- Patients with a tumor of the anterior pituitary
- Patients who have received emetogenic anti-cancer chemotherapy in the previous 4 weeks
- Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
- Patients who have previously participated in this study or who have participated in another interventional clinical study involving pharmacological therapy within the previous 28 days (or longer exclusion period, if required by national or local regulations)
- Where local laws/regulations require: patients under legal protection
- Patients scheduled to receive only a local anesthetic and/or regional neuraxial (intrathecal or epidural) block (without general anesthesia) or to receive general anesthesia involving total intravenous anesthesia (TIVA) with propofol
- Patients who, in the opinion of the Investigator, are expected to remain ventilated for a significant period after surgery
- Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
- Patients who are expected to receive systemic pre/peri-operative corticosteroid therapy other than as anti-emetic prophylaxis
- Patients receiving amisulpride for any indication within the 2 weeks prior to randomization
- Patients known to be allergic to amisulpride or any of the excipients of amisulpride drug product; or to dexamethasone or ondansetron
- Patients with a significant ongoing history of vestibular disease or dizziness
- Patients being treated with regular anti-emetic therapy (dosed at least three times per week), which is still ongoing less than 1 week prior to screening
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.