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

14 augusti 2015 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

196

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02215
        • Planned Parenthood

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Standard sedation dose
IV sedation dose calculated using current standard of care
Övrig: Standard care
IV sedation dosing calculated by standard care.
Experimentell: Algorithm
IV sedation dose calculated by study algorithm
Övrig: Algorithm
IV sedation dosing calculated by algorithm

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain with suction curettage
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain with paracervical block
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Doses given over the duration of the study
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Planned Parenthood League of Massachusetts

Samarbetspartners

Society of Family Planning

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2013

Primärt slutförande (Faktisk)

1 juli 2015

Avslutad studie (Faktisk)

1 juli 2015

Studieregistreringsdatum

Först inskickad

1 november 2013

Först inskickad som uppfyllde QC-kriterierna

19 november 2013

Första postat (Uppskatta)

25 november 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

17 augusti 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 augusti 2015

Senast verifierad

1 augusti 2015

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • SFPRF7-6

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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