interventional
N/A
1 country
1
The aim of this study is to investigate the effect of adding s-ketamine to a multimodal pain approach of acetaminophen and opioids compared to placebo with the same multimodal pain approach, on total opioid consumption after craniotomy in patients with drug-resistant temporal lobe epilepsy. The total opioid consumption will be measured 5 times in the first 7 days after operation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2024
Actual (reported)The primary endpoint is the total postoperative opioid consumption at the 7th postoperative day with interim measurements at 24, 48, 72 and 96 hours postoperatively.
Secondary endpoints will be the length of hospital stay, patient health-related quality of life (RAND SF-36 questionnaire), psychological parameters (questionnaires below cited), adverse events, and postoperative pain scores (VAS+NRS) during the first 7 postoperative days.
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These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
ESKETAMINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
ESKETAMINE
Named ingredient: Esketamine
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Maastricht University Medical Center+
Maastricht, 6229 HX, Netherlands
Secretariaat Neurochirurgie MUMC+
First Submitted
October 11, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Diclofenac Administered Before Skull Operations Reduces the Severity of Headache After the Intervention
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