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POISON – Perioperative Safety and Effective Opioid Dosing in Chronic Opioid Use – a Randomized Clinical Study

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526719-13-00
Enrollment
318
Registered
2026-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid dependent chronic pain

Brief summary

Occurrence of SpO2<92% for =/>60 seconds after admission to the PACU

Detailed description

Time to pain <3 in Numeric Rating Scale 0-10 (NRS) in regards of new surgical pain, Total number of administered opioid doses in Post-Operative Care Unit (PACU), Total number of administered opioid doses from baseline through the following 24h, Standard collected postoperative vital signs and other data (i.e. cumulated duration of desaturation, bradypnea (RF <8/min), Need for supplemental oxygen to maintain SpO2 >94%, Sedation scores (Modified Aldrete Score / Richmond Agitation Sedation Score), Pain Scores (Numeric Rating Scale 0-10), Number of patients withdrawn dur to insufficient analgesia (NRS>7) after 6. continuing doses, Postoperative nausea and vomiting (PONV), Time to pain <5 in Numeric Rating Scale 0-10 (NRS) in regards of new surgical pain

Interventions

DRUGOxycodone Kalceks 10 mg/ml injeksjons-/infusjonsvæske
DRUGoppløsning
DRUGMorfin "DAK"
DRUGinjektionsvæske
DRUGopløsning

Sponsors

Region Hovedstaden
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Occurrence of SpO2<92% for =/>60 seconds after admission to the PACU

Secondary

MeasureTime frame
Time to pain <3 in Numeric Rating Scale 0-10 (NRS) in regards of new surgical pain, Total number of administered opioid doses in Post-Operative Care Unit (PACU), Total number of administered opioid doses from baseline through the following 24h, Standard collected postoperative vital signs and other data (i.e. cumulated duration of desaturation, bradypnea (RF <8/min), Need for supplemental oxygen to maintain SpO2 >94%, Sedation scores (Modified Aldrete Score / Richmond Agitation Sedation Score), Pain Scores (Numeric Rating Scale 0-10), Number of patients withdrawn dur to insufficient analgesia (NRS>7) after 6. continuing doses, Postoperative nausea and vomiting (PONV), Time to pain <5 in Numeric Rating Scale 0-10 (NRS) in regards of new surgical pain

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 9, 2026