Clinical trial NCT01350622: Efficacy of PENNSAID® for Pain Management in the Emergency Department
Official title: Efficacy of PENNSAID® for Pain Management in the Emergency Department
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain
Ankle Sprain
Keywords: pain management
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2011-05-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac under double blind conditions using a growth curve approach to pain measurement. The investigators will test the hypothesis that PENNSAID will provide more rapid pain relief than oral diclofenac during the ED visit. The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the emergency department (ED) visit.


Eligibility criteria: Inclusion:

-We will include ED patients presenting with an acutely painful ankle sprain for which NSAIDs constitute standard of care pain management.

The following will be excluded:

* Those with lacerations, bites, burns
* any head trauma
* pregnant
* anyone with a pre-existing chronic pain condition
* inflammatory intestinal disorders such as Crohn's disease or ulcerative colitis
* anyone regularly using another NSAID or anti-coagulation medication
* anyone who has experienced asthma after NSAID use
* compromised cognitive abilities
* a significant co-morbidity that will compromise participation
* had joint replacements
* known hypersensitivity to diclofenac or allergic responses to NSAIDs as a class
* active stomach and/or duodenal ulceration or gastrointestinal bleeding
* anyone admitted with severe active bleeding
* recent heart surgery
* severe liver or renal insufficiency
* prisoner
* mentally disabled patients
* wards of the state
* cognitive or decisional impairment

Primary outcomes:
measure: Change in pain score
timeFrame: Measure at 5 minute intervals for the duration of the ER visit
Secondary outcomes:
measure: pain trajectory model
timeFrame: nine months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Richard Chapman, PhD
role: STUDY_DIRECTOR
affiliation: University of Utah
name: Virgil Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baer PA, Thomas LM, Shainhouse Z. Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomised controlled, 6-week trial [ISRCTN53366886]. BMC Musculoskelet Disord. 2005 Aug 8;6:44. doi: 10.1186/1471-2474-6-44.
citation: Chapman CR, Donaldson GW, Davis JJ, Bradshaw DH. Improving individual measurement of postoperative pain: the pain trajectory. J Pain. 2011 Feb;12(2):257-62. doi: 10.1016/j.jpain.2010.08.005. Epub 2011 Jan 15.
citation: Moen MD. Topical diclofenac solution. Drugs. 2009;69(18):2621-32. doi: 10.2165/11202850-000000000-00000.
citation: Pritchard PH, Brindley DN. Studies on the ethanol-induced changes in glycerolipid synthesis in rats and their partial reversal by N-(2-benzoyloxyethyl)norfenfluramine (benfluorex). J Pharm Pharmacol. 1977 Jun;29(6):343-9. doi: 10.1111/j.2042-7158.1977.tb11332.x. No abstract available.
citation: Galer BS. A comparative subjective assessment study of PENNSAID(R) and Voltaren Gel(R), two topical formulations of diclofenac sodium. Pain Pract. 2011 May-Jun;11(3):252-60. doi: 10.1111/j.1533-2500.2010.00420.x. Epub 2010 Sep 20.
citation: Roth SH, Shainhouse JZ. Efficacy and safety of a topical diclofenac solution (pennsaid) in the treatment of primary osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled clinical trial. Arch Intern Med. 2004 Oct 11;164(18):2017-23. doi: 10.1001/archinte.164.18.2017.
citation: Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. doi: 10.1016/j.annemergmed.2003.11.019.
citation: Todd KH, Ducharme J, Choiniere M, Crandall CS, Fosnocht DE, Homel P, Tanabe P; PEMI Study Group. Pain in the emergency department: results of the pain and emergency medicine initiative (PEMI) multicenter study. J Pain. 2007 Jun;8(6):460-6. doi: 10.1016/j.jpain.2006.12.005. Epub 2007 Feb 15.
citation: Towheed TE. Pennsaid therapy for osteoarthritis of the knee: a systematic review and metaanalysis of randomized controlled trials. J Rheumatol. 2006 Mar;33(3):567-73.
citation: Tugwell PS, Wells GA, Shainhouse JZ. Equivalence study of a topical diclofenac solution (pennsaid) compared with oral diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. J Rheumatol. 2004 Oct;31(10):2002-12.
citation: Hui X, Hewitt PG, Poblete N, Maibach HI, Shainhouse JZ, Wester RC. In vivo bioavailability and metabolism of topical diclofenac lotion in human volunteers. Pharm Res. 1998 Oct;15(10):1589-95. doi: 10.1023/a:1011911302005.