The NIPA study: A randomized double-blind control clinical trial Naloxegol administration to prevent opioids induced gastrointestinal motility disturbance in brain Injured PAtients.

Conditions

Gastrointestinal motility disorders, Head trauma, Meningeal hemorrhage

Brief summary

Composite criterion defined by the occurrence of one of the following events: - Absence of bowel movements before D6 of hospitalisation - Incidence of VAP before D7 of hospitalisation

Detailed description

Proportion of patient-days achieving the theoretical caloric objective of enteral nutrition (≥25 Kcal/kg/day), Number of patients requiring erythromycin and/or metoclopramide at least once for vomiting during enteral feeding, Number of patients who received at least one rectal laxative for constipation, Time in days to first bowel movement (in case of delayed constipation), Number of patients with late VAP (after 7 days of invasive mechanical ventilation), Number of days without invasive mechanical ventilation, Length of stay in intensive care unit, GOSE score (Glasgow Outcome Scale Extended) at 6 months, Number of patients with an episode of HTIC requiring further sedation, targeted temperature control, introduction of barbiturates, or decompression craniectomy.

Related papers

No related papers found yet.

Interventions

DRUGMoventig 25 mg film-coated tablets

DRUGPlacebo of Moventif 25mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Composite criterion defined by the occurrence of one of the following events: - Absence of bowel movements before D6 of hospitalisation - Incidence of VAP before D7 of hospitalisation	—

Secondary

Measure	Time frame
Proportion of patient-days achieving the theoretical caloric objective of enteral nutrition (≥25 Kcal/kg/day), Number of patients requiring erythromycin and/or metoclopramide at least once for vomiting during enteral feeding, Number of patients who received at least one rectal laxative for constipation, Time in days to first bowel movement (in case of delayed constipation), Number of patients with late VAP (after 7 days of invasive mechanical ventilation), Number of days without invasive mechanical ventilation, Length of stay in intensive care unit, GOSE score (Glasgow Outcome Scale Extended) at 6 months, Number of patients with an episode of HTIC requiring further sedation, targeted temperature control, introduction of barbiturates, or decompression craniectomy.	—

Measure

Time frame

Proportion of patient-days achieving the theoretical caloric objective of enteral nutrition (≥25 Kcal/kg/day), Number of patients requiring erythromycin and/or metoclopramide at least once for vomiting during enteral feeding, Number of patients who received at least one rectal laxative for constipation, Time in days to first bowel movement (in case of delayed constipation), Number of patients with late VAP (after 7 days of invasive mechanical ventilation), Number of days without invasive mechanical ventilation, Length of stay in intensive care unit, GOSE score (Glasgow Outcome Scale Extended) at 6 months, Number of patients with an episode of HTIC requiring further sedation, targeted temperature control, introduction of barbiturates, or decompression craniectomy.

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Countries

France

Outcome results

None listed