Use of an Algorithm to Determine IV Sedation Dosing During First-trimester Surgical Abortion
14. august 2015 oppdatert av: Planned Parenthood League of Massachusetts
This study aims to compare an algorithm for IV sedation dosing to the current standard of care in patients undergoing first trimester surgical abortion.
The primary outcome is subjects' pain score with suction curettage on a 0-100 21-point scale.
Secondary outcomes include pain scores with cervical dilation and 15 minutes post-procedure, subjective pain ratings, incidents of side effects and adverse events, the frequency of additional doses of medication, recovery room time, and physician assessment of and satisfaction with pain control.
Investigators hypothesize that this algorithm will result in improved pain control, decreased frequency of additional medication doses, improved patient and physician satisfaction, without differences in side effects, adverse events or recovery room time.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
196
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Planned Parenthood
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Women age 18 or older seeking surgical abortion at Planned Parenthood League of Massachusetts (PPLM)
- Gestational age less than or equal to 13+6, confirmed by ultrasound
- Eligible for surgical abortion according to PPLM protocols
- Eligible for IV sedation per PPLM protocol, and desiring IV sedation for pain management
Exclusion Criteria:
- Choice of local anesthesia for pain control
- Hypersensitivity to midazolam or fentanyl
- Ineligible for IV sedation per PPLM protocol
- Need for cervical ripening with either misoprostol or mechanical priming agent (laminaria/Dilapan)
- Unable or unwilling to complete required study procedures
- Previous participation in the study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Standard sedation dose
IV sedation dose calculated using current standard of care
|
IV sedation dosing calculated by standard care.
|
|
Eksperimentell: Algorithm
IV sedation dose calculated by study algorithm
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IV sedation dosing calculated by algorithm
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain with suction curettage
Tidsramme: Measured on Day 1 (day of enrollment), immediately (within one minute) after completion of suction curettage and speculum removal
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Subjects' pain score with suction curettage on a 0-100 21-point scale
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Measured on Day 1 (day of enrollment), immediately (within one minute) after completion of suction curettage and speculum removal
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain with paracervical block
Tidsramme: Measured on Day 1 (day of enrollment), immediately after paracervical block
|
Pain with paracervical block will be measured (a) on a 21-point 0 to 100 scale (in increments of five), and (b) on a subjective scale of "no pain, mild pain, moderate pain or severe pain."
Pain will be measured immediately after paracervical block.
|
Measured on Day 1 (day of enrollment), immediately after paracervical block
|
|
Pain with cervical dilation
Tidsramme: Measured on Day 1 (day of enrollment), immediately after cervical dilation
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Pain with cervical dilation will be measured (a) on a 21-point 0 to 100 scale (in increments of five), and (b) on a subjective scale of "no pain, mild pain, moderate pain or severe pain."
Pain with cervical dilation will be measured immediately after cervical dilation.
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Measured on Day 1 (day of enrollment), immediately after cervical dilation
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|
Post-operative pain
Tidsramme: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
|
Post-operative pain will be measured (a) on a 21-point 0 to 100 scale (in increments of five), and (b) on a subjective scale of "no pain, mild pain, moderate pain or severe pain."
Pain will be measured 15 minutes post-operatively when the patient is in the recovery room.
|
Measured on Day 1 (day of enrollment), 15 minutes post-operatively
|
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Patient satisfaction with pain control
Tidsramme: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
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Patients will be asked about their general satisfaction with pain control, what their pain was compared to what they expected, whether they would chose the same pain management strategy again, and whether they would recommend their strategy of pain management to a friend.
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Measured on Day 1 (day of enrollment), 15 minutes post-operatively
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Side effects
Tidsramme: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
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Investigators will assess side effects for all patients, including nausea, vomiting, dizziness, and drowsiness.
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Measured on Day 1 (day of enrollment), 15 minutes post-operatively
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Doses given over the duration of the study
Tidsramme: Measured on Day 1 (day of enrollment), intraoperatively
|
To assess whether use of the algorithm changes physician's behavior in the standard care arm, investigators will also examine doses given over the duration of the study, to see if a "learning curve" develops among the physicians based on their experience with the algorithm.
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Measured on Day 1 (day of enrollment), intraoperatively
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|
Physician assessment of pain control
Tidsramme: Measured on Day 1 (day of enrollment), post-operatively
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Investigators will also have the physician assess patients' pain control, whether they felt the dose was appropriate and how easy or difficult it was to determine the patients' doses of pain medication.
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Measured on Day 1 (day of enrollment), post-operatively
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2013
Primær fullføring (Faktiske)
1. juli 2015
Studiet fullført (Faktiske)
1. juli 2015
Datoer for studieregistrering
Først innsendt
1. november 2013
Først innsendt som oppfylte QC-kriteriene
19. november 2013
Først lagt ut (Anslag)
25. november 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. august 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. august 2015
Sist bekreftet
1. august 2015
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- SFPRF7-6
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