- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03135470
Pain Medication After Ambulatory Surgery
Adequacy and Adverse Effects of Pain Medication After Ambulatory Surgery, Observational Study
Studieoversikt
Status
Detaljert beskrivelse
After informed consent, all patients operated as ambulatory surgery patients during the study period are given a letter interview for pain, pain medication and symptom follow up. They are also given a return envelope (with paid postal fee) to return the interview.
Based on the results of the first interview phase, our pain medication practice is reconsidered by anesthetists and surgeons to create a standard operating protocol for pain medication. The standard operating protocol is informed to personnel. Then, patient interview phase is repeated for another 3 months.
Then, investigators continue with a pilot study on using a mobile phone app in evaluating patients pain, sufficient pain medication and adverse effects. All patient with informed consent, suitable mobile phone, and willing to use it for reporting pain for hospital personnel are contacted via the mobile app. Other patients operated during that study period are interviewed by either letter interview or phone interview. Investigators try to estimate whether mobile apps are suitable for pain and medication follow-up.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Vantaa, Finland, 00029
- Helsinki University (Central) Hospital, Peijas Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
All plenipotentiary patients, operated as ambulatory surgery patients in our clinic during the study period, with informed consent
Exclusion Criteria:
We do not accept patients, who are not plenipotentiary (minor, incompetent, prisoners, conscript in military service) or do not understand finnish or swedish written information
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Current practice group
All plenipotentiary ambulatory surgery patients, with informed consent, during the three month study period
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Standard operating protocol group
All plenipotentiary ambulatory surgery patients, with informed consent, during the three month study period after creating and informing standardized operating protocol
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Mobile phone app group
All plenipotentiary ambulatory surgery patients during the three month study period with informed consent to use mobile phone app in assesment of pain and pain medication
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Medication
Tidsramme: up to two days after surgery
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all pain medication used (reported By the patient)
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up to two days after surgery
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Pain
Tidsramme: up to two days after surgery
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Pain assessed By the patient By numerical rating scale 0-10
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up to two days after surgery
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Adverse effects
Tidsramme: up to two days after surgery
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Adverse effects of the pain medication, study questions
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up to two days after surgery
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Sufficiency of pain medication
Tidsramme: up to two days after surgery
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Whether the pain medication used was sufficient or not, study questions
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up to two days after surgery
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Elina Reponen, MD/PhD, Senior physician, Deputy Chief of Department
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HUS235/2017
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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