The Use of Intranasal Ketoralac for Pain Management (Sprix)
Evaluating Post-operative Pain Management Efficacy of Intra Nasal Ketorolac in Ambulatory Urological Surgeries-A Randomized Double-blinded Placebo Controlled Study
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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New York
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Bronx、New York、アメリカ、10461
- Montefiore Medical Center- Weiler Division
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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15.75 mg of Sprix in each nostril 20 minutes before end of surgery
他の名前：
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プラセボコンパレーター：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.
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15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Post-operative Opioid Requirements
時間枠：3 hours after surgery
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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.
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3 hours after surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Post Operative Pain Score
時間枠：30 minutes after surgery
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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.
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30 minutes after surgery
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Post Operative Pain Score
時間枠：1 hour after surgery
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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.
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1 hour after surgery
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Post Operative Pain Scale
時間枠：2 hours after surgery
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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.
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2 hours after surgery
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Postoperative Side Effects
時間枠：24 hours after procedure
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To find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population.
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24 hours after procedure
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協力者と研究者
捜査官
- スタディディレクター：Singh Nair, MD、Montefiore Medical Center
出版物と役立つリンク
一般刊行物
- 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.
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本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 12-02-244
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