Efficacy of PENNSAID® for Pain Management in the Emergency Department

Pain Clinical Trial

Official title:

Efficacy of PENNSAID® for Pain Management in the Emergency Department

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01350622
• Other study ID #: 49065
• Status: Withdrawn
• Phase: N/A
• First received: April 29, 2011
• Last updated: December 19, 2016
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain
• Emergencies
• Pain

Intervention

Drug:
• PENNSAID
active treatment with PENNSAID and oral placebo. Subjects will apply 40 drops of Pennsaid to the affected ankle joint once, and will take a single placebo pill.
• Diclofenac hydroxyethylpyrrolidine
active treatment oral Diclofenac and PENNSAID placebo. Patients will take a single 50mg dose of oral diclofenac and will apply 40 drops of placebo lotion (2.3% DMSO) to the affected ankle once.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Medtronic - MITG

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View Citation

Galer BS. A comparative subjective assessment study of PENNSAID® and Voltaren Gel®, two topical formulations of diclofenac sodium. Pain Pract. 2011 May-Jun;11(3):252-60. doi: 10.1111/j.1533-2500.2010.00420.x. — View 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. — View Citation

Moen MD. Topical diclofenac solution. Drugs. 2009;69(18):2621-32. doi: 10.2165/11202850-000000000-00000. — View 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. — View 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. — View Citation

Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. Review. — View 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. — View 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. Review. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain score	Compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac.	Measure at 5 minute intervals for the duration of the ER visit	No
Secondary	pain trajectory model	The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the ED visit	nine months	No