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Ketamine: Comparison of IV Push vs. IV Drip

19. oktober 2017 opdateret af: Antonios Likourezos

Comparison of Intravenous Push Dose of Low Dose Ketamine to Short Infusion of Low Dose Ketamine for Treatment of Moderate to Severe Pain in the Emergency Department: A Prospective, Randomized, Double-Blind Study

Our previous published research comparing the efficacy of intravenous ketamine to morphine has shown ketamine to provide equivalent relief of moderate to severe acute pain in emergency medicine patients. Secondary analysis of the previous published research has also revealed ketamine to have statistically more side effects. The investigators believe that increasing the time of administration of the ketamine, from a push injection to a drip infusion, will minimize the side effects experienced by recipients of ketamine.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Ketamine is a noncompetitive N-methyl D-aspartate (NMDA) receptor antagonist that blocks the release of excitatory neurotransmitter glutamate and provides anesthesia, amnesia and analgesia by virtue of decreasing central sensitization and "wind-up" phenomenon. At low (sub-dissociative, analgesics) doses of 0.1-0.4 mg/kg either as an adjunct to opioid analgesics or as a single agent, ketamine provides good analgesia while preserving airway patency, ventilation, and cardiovascular stability. In addition, the low-dose of ketamine increases the analgesic potency of opioids thus decreasing their requirements. Several recent studies of low-dose ketamine administered together with morphine provided acceptable pain relief to 55-60% of patients with minor side effects of dizziness, nausea and feeling of unreality. More recently the investigators conducted a research comparing Low-Dose Ketamine to Morphine for Moderate to Severe Pain in the Emergency Department with respect its analgesic efficacy and safety. Results demonstrated similar pain relief at 30 min between 2 groups. However, 70% of patients in ketamine group had minor side effects at 5 min and 35% of patients at 30 min, as compared to 51% at 5 min. and 31% at 15 min. in the morphine group. The most common side effects reported by ketamine patients were dizziness, nausea, feeling of unreality, and mood changes.

Based on the above mentioned data from our previous published research study, we hypothesized that low-dose ketamine given as a short infusion over 15 min will provide similar analgesic efficacy as an intravenous push-dose but with much less side effects. There are several research papers that support our hypothesis.

A prospective, randomized trial compared two analgesic regimens, morphine with ketamine (K group) or morphine with placebo (P group) for severe acute pain in 73 trauma patients with a visual analog scale (VAS) score of at least 60/100. Morphine was administered at 0.1mg/kg and patients in the K group received 0.2 mg/kg of intravenous ketamine over 10 minutes, and the patients in the P group received isotonic sodium chloride solution. The results showed comparable change in VAS score at 30 minutes (34 mm (K) vs. 39 mm (P)) but reduced morphine consumption in the ketamine group (0.14 mg/kg (K) vs 0.2 mg/kg (P)).

A double-blind trial of 40 adult patients with acute musculoskeletal trauma compared a low-dose ketamine by subcutaneous infusion (0.1 mg/kg/h) with intermittent morphine (0.1 mg/kg IV every 4 hours ) and demonstrated better pain relief, less sedation and less nausea and vomiting with ketamine infusion than with intermittent morphine. In addition, none of the patients in ketamine group required supplementary analgesia.

A prospective case series of 20 unselected adult ED patients with acute pain that evaluated analgesic feasibility of low-dose ketamine infusion was conducted in an urban public hospital over a course of 5 months. Patients received 15mg of intravenous push dose ketamine that was followed by continuous ketamine infusion at 20mg per hour for one hour. Optional morphine (4 mg) was offered at 20, 40 and 60 minutes. Pain intensity was assessed at regular intervals for 2 hours using a 10-point verbal numerical rating scale (NRS), along with vital signs and levels of sedation. Results showed that fifteen patients reported clinically significant pain relief at 60 minutes and 13 at 120 minutes; and eighteen patients reported mild or modest side effects including dizziness, fatigue and headache.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • New York
      • Brooklyn, New York, Forenede Stater, 11219
        • Maimonides Medical Center

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

Inclusion Criteria:

  • Emergency Medicine patients
  • Adult patients (18-65 years of age)
  • Moderate to severe pain (Numeric Pain Rating Score =5).
  • Patients must be awake, alert and oriented to time, place and person.
  • Patients must be able to demonstrate understanding of the informed consent, and also able to verbalize how much pain they are having on the 10 point Numeric Rating Pain Scale, and the nature of the side effects they may be experiencing from the IV analgesia

Exclusion Criteria:

  • Patients with cognitive deficits that are not able to demonstrate understanding as described above.
  • Patient's reported weight of less than 45kg or more than 115kg.
  • Patients with altered mental status, alcohol intoxication, eye trauma.
  • Patients with hemodynamic instability (Systolic Blood pressure <90), and malignant hypertension.
  • allergy to ketamine
  • Pregnancy or breast feeding.

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: IV Push Group
Ketamine medication given via IV Push. IV Push is the intervention.
IV Push or or IV Drip
Aktiv komparator: IV Drip Group
Ketamine medication given via IV Drip. IV Drip is the intervention.
IV Push or or IV Drip

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Rate of Feeling Unreality
Tidsramme: 30 minutes
Overall rate of feeling of unreality as measured by Side Effects Rating Scale for Dissociative Anesthetics (SERSDA)
30 minutes

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Studieleder: Christian Fromm, MD, Maimonides Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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 (Faktiske)

1. april 2015

Primær færdiggørelse (Faktiske)

15. august 2016

Studieafslutning (Faktiske)

28. februar 2017

Datoer for studieregistrering

Først indsendt

9. februar 2015

Først indsendt, der opfyldte QC-kriterier

12. februar 2015

Først opslået (Skøn)

13. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

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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