Randomized, double-blind, Phase 2/3 study of IV amisulpride as prevention of post-operative nausea and vomiting in pediatric patients

Conditions

post-operative nausea and vomiting in pediatric patients

Brief summary

Complete Response (absence of PONV), defined as no vomiting/retching and no use of anti-emetic rescue medication, during the first 24 hours after completion of surgery

Detailed description

Efficacy: Occurrence of post-operative vomiting/retching, Efficacy: Use of rescue medication, Efficacy: Occurrence and severity of post-operative nausea, Efficacy: Time to emergence of PONV, Efficacy: Time to emergence of vomiting/retching, significant nausea, and rescue medication, individually, Efficacy: Different variables (complete response, vomiting/retching, use of rescue medication) during different time ranges after the end of surgery (0-2 h, 2-6 h and 6-24 h), Efficacy: The above variables in the sub-groups of patients who did and did not receive opioid analgesia, Safety: The nature and frequency of adverse events and laboratory and ECG abnormalities, Key pharmacokinetics parameters

Related papers

No related papers found yet.

Interventions

DRUGAmisulpride

DRUGDEXAMETHASONE PHOSPHATE

DRUGONDANSETRON

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Complete Response (absence of PONV), defined as no vomiting/retching and no use of anti-emetic rescue medication, during the first 24 hours after completion of surgery	—

Secondary

Measure	Time frame
Efficacy: Occurrence of post-operative vomiting/retching, Efficacy: Use of rescue medication, Efficacy: Occurrence and severity of post-operative nausea, Efficacy: Time to emergence of PONV, Efficacy: Time to emergence of vomiting/retching, significant nausea, and rescue medication, individually, Efficacy: Different variables (complete response, vomiting/retching, use of rescue medication) during different time ranges after the end of surgery (0-2 h, 2-6 h and 6-24 h), Efficacy: The above variables in the sub-groups of patients who did and did not receive opioid analgesia, Safety: The nature and frequency of adverse events and laboratory and ECG abnormalities, Key pharmacokinetics parameters	—

Measure

Time frame

Efficacy: Occurrence of post-operative vomiting/retching, Efficacy: Use of rescue medication, Efficacy: Occurrence and severity of post-operative nausea, Efficacy: Time to emergence of PONV, Efficacy: Time to emergence of vomiting/retching, significant nausea, and rescue medication, individually, Efficacy: Different variables (complete response, vomiting/retching, use of rescue medication) during different time ranges after the end of surgery (0-2 h, 2-6 h and 6-24 h), Efficacy: The above variables in the sub-groups of patients who did and did not receive opioid analgesia, Safety: The nature and frequency of adverse events and laboratory and ECG abnormalities, Key pharmacokinetics parameters

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Countries

France, Germany

Outcome results

None listed