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Dose Response of Ketorolac in Knee Arthroscopy

20. september 2018 opdateret af: Medical University of South Carolina

Dose Response of Ketorolac in Out-Patients Undergoing Knee Arthroscopy

Ketorolac is administered as current practice to the majority of patients undergoing knee arthroscopy, the appropriate dose of ketorolac to be administered has not been evaluated.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Past studies have examined different doses of ketorolac administered to patients after spinal fusion surgery and found that 7.5 mg every 6 hours was as effective as 15 or 30 mg every 6 hours in decreasing postoperative pain and patient opiate consumption. Since ketorolac side effects such as gastrointestinal and surgical site bleeding seem to be dose related, utilizing a lower dose of ketorolac may be more efficacious.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

112

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
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29461
        • Medical University of South Carolina

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 til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Population: Patients scheduled for outpatient knee arthroscopy under general anesthesia with ASA physical status I-III ages 18-65 years old. All subjects will receive informed consent. Subjects will not be eligible to participate if they cannot provide informed consent. Non-English speaking patients will not be included due to the limited time and availability of translators.

Inclusion Criteria:

  1. Ability to consent and desire to participate in study
  2. Outpatient knee arthroscopy with Dr. C. David Geier
  3. ASA physical status I-III
  4. 18-65 years old
  5. Over 50 kg (110 pounds)
  6. General anesthesia

Exclusion Criteria

  1. Any contraindication to receiving a non-steroidal antiinflammatory medication (including but not limited to allergy to any non-steroidal antiinflammatory medications including aspirin; chronic renal insufficiency; history of gastric ulcers, gastritis, peptic ulcers or gastrointestinal bleeding; severe volume depletion; presence of cerebrovascular bleeding or high risk of bleeding)
  2. Allergy to propofol, fentanyl or hydromorphone.
  3. Any chronic painful conditions requiring opioid use for over the last 6 months
  4. Emergency surgery
  5. Altered mental status (not oriented to place, person or time)
  6. Pregnant or lactating patients
  7. Patient is taking non-steroidal antiinflammatory medications (including aspirin)1 at home and took that medication on day of surgery.
  8. Non-English speaking
  9. Patient refusal to study
  10. Patient refusal or not a candidate for general anesthesia with Laryngeal Mask Airway (LMA)

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 0 mg of Ketorolac
participant receives 0 mg of Ketorolac
Medicin: Ketorolac Dose
Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
Andre navne:
  • Toradol
Aktiv komparator: 7.5 mg of Ketorolac
participant receives 7.5 mg of Ketorolac
Medicin: Ketorolac Dose
Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
Andre navne:
  • Toradol
Aktiv komparator: 15 mg Ketorolac
participant receives 15 mg of Ketorolac
Medicin: Ketorolac Dose
Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
Andre navne:
  • Toradol
Aktiv komparator: 30 mg Ketorolac
participant receives 30mg of Ketorolac
Medicin: Ketorolac Dose
Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
Andre navne:
  • Toradol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PACU Opiate Consumption
Tidsramme: Less than 1 day (PACU stay in the postoperative period)
Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME).
Less than 1 day (PACU stay in the postoperative period)

Samarbejdspartnere og efterforskere

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

Sponsor

Medical University of South Carolina

Efterforskere

  • Ledende efterforsker: Sylvia H Wilson, MD, Medical University of South Carolina

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. marts 2012

Primær færdiggørelse (Faktiske)

15. december 2016

Studieafslutning (Faktiske)

15. december 2016

Datoer for studieregistrering

Først indsendt

26. juni 2014

Først indsendt, der opfyldte QC-kriterier

1. juli 2014

Først opslået (Skøn)

4. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. september 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Ketorolac Knee Arthroscopy

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 .

Kliniske forsøg med Ketorolac Dose

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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