The Use of Intranasal Ketoralac for Pain Management (Sprix)
3 februari 2020 uppdaterad av: Singh Nair, Montefiore Medical Center
Evaluating Post-operative Pain Management Efficacy of Intra Nasal Ketorolac in Ambulatory Urological Surgeries-A Randomized Double-blinded Placebo Controlled Study
Despite an overall reduction in the perioperative complication rate, post operative pain management after ureteroscopic removal of stones (URS) remains a major factor delaying discharge of patients.
The investigators hypothesize that perioperative usage of intranasal ketorolac will provide a reduction in post operative opioid requirements, better post operative pain control, higher anesthesia satisfaction and faster recovery.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The prevalence and incidence of urolithiasis, or kidney stone disease, are increasing in the general population. Life-time incidence of urolithiasis is estimated to be between 5%- 12%. The treatment of kidney stones depends on stone type and size, symptom severity, and the presence of obstruction.
URS is a common ambulatory procedure as improved technological advances and increased clinical utilization have helped decrease postoperative complications. Despite an overall reduction in the perioperative complication rate, post operative pain management after URS remains a major factor delaying discharge of patients.
Post operative pain after URS is usually treated with opioids and non steroidal anti inflammatory drugs. Intranasal ketorolac (SprixTM) is an FDA approved pain formulation for short term management (5 days) of moderate to moderately severe pain that requires analgesia at the opioid level. The efficacy of intranasal ketorolac formulation was demonstrated in placebo-controlled studies in patients following major surgeries.
The primary objective of the study is to evaluate the role perioperative usage of single-dose of intranasal ketorolac on immediate post operative opioid requirements. Secondary objectives of the study are to (a) evaluate the post operative pain score 30 minutes after surgery, 1 hour after surgery, and 2 hours after surgery, (b) find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population, (c) find the level of anesthesia satisfaction in the target population, (d) find the time to discharge in the target population, (e) compare the two groups post anesthesia discharge score.
Studietyp
Interventionell
Inskrivning (Faktisk)
50
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
New York
-
Bronx, New York, Förenta staterna, 10461
- Montefiore Medical Center- Weiler Division
-
-
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 till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Ureteroscopic stone removal surgeries with stenting
- Age ≥ 18 years and < 65 years
- Stable patient with stable vital signs
- Mentally competent and is able to understand consent form
Exclusion Criteria:
- Unstable patients
- Patients with multiple trauma sites
- Patients with allergies to ketorolac or any of the components in the nasal spray preparation
- Patients with active peptic ulcer disease
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
- Renal disease or at risk for renal failure due to volume depletion
- Pregnant or nursing mothers
- Nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor)
- Any other contraindication to the use of Sprix, or in whom use of Sprix would not be consistent with the approved package insert
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intranasal Ketoralac
A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery.
15.75 mg of Sprix will be sprayed in each nostril.
|
15.75 mg of Sprix in each nostril 20 minutes before end of surgery
Andra namn:
|
|
Placebo-jämförare: Placebo
A single dose of placebo will be administered 20 minutes before the end of surgery.
15.75 mg of the placebo will be sprayed in each nostril.
|
15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Post-operative Opioid Requirements
Tidsram: 3 hours after surgery
|
this study will assess the effect of perioperative usage of single-dose of intranasal ketorolac on post operative opioid requirements within 3 hours after surgery.
|
3 hours after surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Post Operative Pain Score
Tidsram: 30 minutes after surgery
|
To evaluate the post operative pain score using the Visual Analog Scale (VAS) 30 minutes after surgery.
The scale for VAS is 0 is no pain to 10 being the worst pain.
|
30 minutes after surgery
|
|
Post Operative Pain Score
Tidsram: 1 hour after surgery
|
To evaluate the post operative pain score using the Visual Analog Scale (VAS) 1 hour after surgery.
The scale for VAS is 0 is no pain to 10 being the worst pain.
|
1 hour after surgery
|
|
Post Operative Pain Scale
Tidsram: 2 hours after surgery
|
To evaluate the post operative pain score using the Visual Analog Scale (VAS) 2 hours after surgery.
The scale for VAS is 0 is no pain to 10 being the worst pain.
|
2 hours after surgery
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Postoperative Side Effects
Tidsram: 24 hours after procedure
|
To find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population.
|
24 hours after procedure
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Singh Nair, MD, Montefiore Medical Center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Singla N, Singla S, Minkowitz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010 Aug;26(8):1915-23. doi: 10.1185/03007995.2010.495564. Erratum In: Curr Med Res Opin. 2012 Jun;28(6):1052.
- Moodie JE, Brown CR, Bisley EJ, Weber HU, Bynum L. The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesth Analg. 2008 Dec;107(6):2025-31. doi: 10.1213/ane.0b013e318188b736. Erratum In: Anesth Analg. 2009 Mar;108(3):991. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text.
- Ahn ST, Kim JH, Park JY, Moon du G, Bae JH. Acute postoperative pain after ureteroscopic removal of stone: incidence and risk factors. Korean J Urol. 2012 Jan;53(1):34-9. doi: 10.4111/kju.2012.53.1.34. Epub 2012 Jan 25.
- Saigal CS, Joyce G, Timilsina AR; Urologic Diseases in America Project. Direct and indirect costs of nephrolithiasis in an employed population: opportunity for disease management? Kidney Int. 2005 Oct;68(4):1808-14. doi: 10.1111/j.1523-1755.2005.00599.x.
- Pak CY, Resnick MI, Preminger GM. Ethnic and geographic diversity of stone disease. Urology. 1997 Oct;50(4):504-7. doi: 10.1016/s0090-4295(97)00307-5.
- Peschel R, Janetschek G, Bartsch G. Extracorporeal shock wave lithotripsy versus ureteroscopy for distal ureteral calculi: a prospective randomized study. J Urol. 1999 Dec;162(6):1909-12. doi: 10.1016/s0022-5347(05)68066-4.
- Tiselius HG. Epidemiology and medical management of stone disease. BJU Int. 2003 May;91(8):758-67. doi: 10.1046/j.1464-410x.2003.04208.x.
- Erhard M, Salwen J, Bagley DH. Ureteroscopic removal of mid and proximal ureteral calculi. J Urol. 1996 Jan;155(1):38-42. Erratum In: J Urol 1996 Mar;155(3):1039.
- Cheung MC, Lee F, Leung YL, Wong BB, Chu SM, Tam PC. Outpatient ureteroscopy: predictive factors for postoperative events. Urology. 2001 Dec;58(6):914-8. doi: 10.1016/s0090-4295(01)01445-5.
- Bromwich EJ, Lockyer R, Keoghane SR. Day-case rigid and flexible ureteroscopy. Ann R Coll Surg Engl. 2007 Jul;89(5):526-8. doi: 10.1308/003588407X187676.
- McAleer SD, Majid O, Venables E, Polack T, Sheikh MS. Pharmacokinetics and safety of ketorolac following single intranasal and intramuscular administration in healthy volunteers. J Clin Pharmacol. 2007 Jan;47(1):13-8. doi: 10.1177/0091270006294597.
- Brown C, Moodie J, Bisley E, Bynum L. Intranasal ketorolac for postoperative pain: a phase 3, double-blind, randomized study. Pain Med. 2009 Sep;10(6):1106-14. doi: 10.1111/j.1526-4637.2009.00647.x. Epub 2009 Jul 6. Erratum In: Pain Med. 2011 Jun;12(6):990. Dosage error in published abstract; MEDLINE/PubMed abstract corrected.
- Grant GM, Mehlisch DR. Intranasal ketorolac for pain secondary to third molar impaction surgery: a randomized, double-blind, placebo-controlled trial. J Oral Maxillofac Surg. 2010 May;68(5):1025-31. doi: 10.1016/j.joms.2009.10.023. Epub 2010 Mar 5.
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 oktober 2012
Primärt slutförande (Faktisk)
1 juni 2014
Avslutad studie (Faktisk)
1 juni 2014
Studieregistreringsdatum
Först inskickad
26 november 2012
Först inskickad som uppfyllde QC-kriterierna
28 november 2012
Första postat (Uppskatta)
29 november 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 februari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 februari 2020
Senast verifierad
1 februari 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urologiska sjukdomar
- Patologiska tillstånd, anatomiska
- Calculi
- Urinvägar
- Urolithiasis
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Agenter från det perifera nervsystemet
- Enzyminhibitorer
- Analgetika
- Sensoriska systemagenter
- Antiinflammatoriska medel, icke-steroida
- Analgetika, icke-narkotiska
- Antiinflammatoriska medel
- Antireumatiska medel
- Cyklooxygenashämmare
- Ketorolac
Andra studie-ID-nummer
- 12-02-244
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 .