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Use of an Algorithm to Determine IV Sedation Dosing During First-trimester Surgical Abortion

14. august 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

196

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Planned Parenthood

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard sedation dose
IV sedation dose calculated using current standard of care
Andet: Standard care
IV sedation dosing calculated by standard care.
Eksperimentel: Algorithm
IV sedation dose calculated by study algorithm
Andet: Algorithm
IV sedation dosing calculated by algorithm

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Subjects' pain score with suction curettage on a 0-100 21-point scale
Measured on Day 1 (day of enrollment), immediately (within one minute) after completion of suction curettage and speculum removal

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
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.
Measured on Day 1 (day of enrollment), immediately after cervical dilation
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
Patient satisfaction with pain control
Tidsramme: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
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.
Measured on Day 1 (day of enrollment), 15 minutes post-operatively
Side effects
Tidsramme: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
Investigators will assess side effects for all patients, including nausea, vomiting, dizziness, and drowsiness.
Measured on Day 1 (day of enrollment), 15 minutes post-operatively

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.
Measured on Day 1 (day of enrollment), intraoperatively
Physician assessment of pain control
Tidsramme: Measured on Day 1 (day of enrollment), post-operatively
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.
Measured on Day 1 (day of enrollment), post-operatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Planned Parenthood League of Massachusetts

Samarbejdspartnere

Society of Family Planning

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2013

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Faktiske)

1. juli 2015

Datoer for studieregistrering

Først indsendt

1. november 2013

Først indsendt, der opfyldte QC-kriterier

19. november 2013

Først opslået (Skøn)

25. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • SFPRF7-6

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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