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A Comprehensive Review of Treating Acute Pain. Kelly W. Jones, Pharm.D., BCPS Florence, South Carolina kjones@mcleodhealth.org. Disclaimer . I have no conflict of interest relating to the material covered in our discussion today. I do not serve on any speaker bureau.

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a comprehensive review of treating acute pain

A Comprehensive Review of Treating Acute Pain

Kelly W. Jones, Pharm.D., BCPS

Florence, South Carolina

kjones@mcleodhealth.org

disclaimer
Disclaimer
  • I have no conflict of interest relating to the material covered in our discussion today.
  • I do not serve on any speaker bureau.
  • I do not have any grants concerning the area of discussion.
2 types of pain
2 types of pain
  • Acute and chronic
  • Nociceptive and neuropathic
    • Nociceptive is sharp, throbbing, aching
      • It is easy to describe, localize
      • Hard to describe if visceral
    • Neuropathic is described as burning, tingling, shooting, stabbing, electrical
  • Both may need opioids and adjuvants
the steps approach
The STEPS Approach
  • Safety
  • Tolerability
  • Efficacy
  • Price
  • Simplicity
the steps approach6
The STEPS approach
  • S Safety
      • respiratory depression
  • T Tolerability
      • itching, constipation, addiction, etc
  • E Efficacy
      • efficacy?
  • P Price
      • depends on delivery system
  • S Simplicity
      • depends on patient and condition
efficacy acute pain
Efficacy - Acute Pain
  • Outcome: # with at least 50% pain relief
pain ladder
Pain Ladder

Nonpharmacologic Approaches

nonpharmacologic approach
Nonpharmacologic Approach
  • Comprehensive therapy with many approaches
    • Spiritual advise
    • Rest
    • Exercise
    • Biofeedback or Psychotherapy
    • Heat/cool packs
    • Hot baths
    • Complementary medicine
pain ladder11
Pain Ladder

Acetaminophen or nonacetylated salicylates

Nonpharmacologic Approaches

acetaminophen
Acetaminophen
  • Analgesic
  • No more than 4 grams per day
  • Extra strength = 500 mg
  • 5 grains = 325 mg
  • Caution in alcoholics and those with liver disease - 2 grams/day limit
  • Caution with warfarin
  • Drug of choice for OA
acetaminophen toxicity
Acetaminophen toxicity
  • Poison of choice in teenagers
    • They don’t consider it dangerous
  • Use nomogram to determine toxicity
  • Measure serum level of acetaminophen after 4 hours of ingestion
  • Antedote: acetylcysteine 140 mg/kg x 1, then 70 mg/kg for 17 more doses
  • Acetadote® (acetylcysteine)
    • Injectable form for acetaminophen overdose
otc analgesics acetaminophen final ruling label changes to reflect new safety information
OTC Analgesics – AcetaminophenFinal ruling – label changes to reflect new safety information

FDA 4/29/09

  • Ingredient “acetaminophen” prominently identified on product’s container and carton
  • Labels contain new warnings that highlight the potential for liver toxicity and warn against
    • Using more than the recommended dose of acetaminophen;
    • Using more than one product (over-the-counter or prescription) containing with acetaminophen
    • Taking acetaminophen with moderate amounts of alcohol.
acetaminophen fda advisory committee options to reduce risk of liver damage
AcetaminophenFDA advisory committee: options to reduce risk of liver damage
  • Reduce the current dose recommendations for maximum adult daily dose and single adult dose
    • Limit single adult dose to maximum of 650 mg
    • Lower max daily dose from 4000mg to 3250 mg
    • Clarify dosing for alcohol users (> 3 drinks/day)
  • Limit dose formulations for over-the-counter liquid preparations
    • Restrict to a single mid-strength concentration
  • Eliminate OTC (and possibly prescription) combination acetaminophen products
      • Vote was 20 to 17 in favor to pull acetaminophen out in combination with narcotics

FDA Advisory Committee public hearing 6/30/09

the best the fda has
The Best the FDA has…
  • Only one study does the argument any justice.
    • Study in Atlanta from 2000 to 2004
      • 94 patients admitted to hospital in 5 yrs with acute liver failure
      • 29 adults with liver failure from acetaminophen
        • 15 were unintentional, 14 intentional overdoses
      • Study defines incidence
        • 5 cases/million/year in Atlanta
        • Extrapolation - 350 unintentional cases/300,000,000/year in USA (0.000001 or 0.0001%)

Am J Gastroent 2007;102:2459-63

do we live in a no risk world
Do we live in a no risk world?
  • 2005 data
    • Odds of dying from any injury - 1 in 2,517
    • Odds of dying from a fall - 1 in 15,085
    • Odds of dying from an auto injury - 1 in 20,331
    • Odds of dying from complications from medical and surgical care - 1 in 111,763
    • Odds of dying from a firearm - 1 in 375,801
    • Odds of having unintentional liver injury from acetaminophen - 1 in 850,000 (NOT “odds of dying”)
    • Odds of dying from fireworks - 1 in 57,588,244

National Safety Council. The odds of dying in 2005

http://www.nsc.org/research/odds.aspx

more beliefs
More beliefs!
  • Acetaminophen in alcoholics
    • 6 trials
    • All trials done with 4 gm
      • There are no 2 gram studies!
    • There were NO changes in liver function as compared to placebo on days 4 and 11 as compared to day 0.
    • No changes in LFT’s in 3 or 5 day study
    • “We do not believe the new studies justify removal of the alcohol warning.”
        • Claim small numbers, people use longer than 10 days
    • Because these new studies do not adequately demonstrate that alcohol use is NOT a risk factor….we believe an alcohol warning continues to be necessary.”
        • Was the study designed to answer this question?

Hepatology 1995;22:767-73; Al Pharm & Ther 2007;26:283-90

Federal Register 2009;74(81):19385-19409

non acetylated salicylates
Non-acetylated Salicylates
  • Does not interfere with platelet aggregation
  • Rarely associated with GI bleeding
  • Does not affect renal function
  • Safe in aspirin allergic patients
  • “Weak” antiinflammatory agents:
    • No RCTs demonstrating efficacy in chronic pain
    • Onset of action slower than NSAIDs
non acetylated salicylates products
Non-acetylated Salicylates Products
  • Diflunisal (Dolobid®)
    • 500 mg - dose is 2 tabs loading dose, then 1 tab twice daily
    • Generic price - $1.00 per tablet
  • Choline magnesium trisalicylate (Trilisate®)
    • 500 mg, 750 mg, 1000 mg tabs
    • Typical dose is 1500 mg BID
  • Salsalate (Disalcid®)
    • 500 mg, 750 mg tabs
  • Magnesium Salicylate
    • Doan’s Pills - OTC
pain ladder21
Pain Ladder

NSAIDs

Acetaminophen or nonacetylated salicylates

Nonpharmacologic Approaches

nsaids
NSAIDs
  • Allergy to aspirin = allergy to NSAIDs
  • If one NSAID does not work, does not mean others will not work.
  • Analgesic effects are single dose
  • Anti-inflammatory effects occur between days 7 and 14
  • Long-acting vs short-acting NSAIDs
  • What happened to the COX-2 inhibitors?
  • Consider monitoring LFT’s in patients taking diclofenac (hepatitis - 1 to 5/100,000, hum..?)
slide23

NSAID-Induced UlcersRisk Reduction through Choice of Agent

  • High: aspirin, indomethacin, ketorolac, meclofenamate, piroxicam, tolmetin
  • Medium: diclofenac, fenoprofen, flurbiprofen, ketoprofen, ibuprofen, naproxen, oxaprozin, sulindac, mefanamic acid
  • Low: etodolac, nabumetone
  • Lowest:celecoxib, non-acetylated salicylates
new nsaids
New NSAIDs
  • Diclofenac epolamine 1.3% (Flector® Patch)
    • NSAID patch for acute pain from strains, sprains, contusions
    • Dose is one patch twice a day
    • Do not apply to damaged skin
    • Do NOT wear while bathing or showering
    • Wash hands after application
    • Come in a box of 2 envelopes, each envelope has 5 patches
    • $156/#30 patches
  • Ibuprofen injection (Caldolor®)
    • Acute pain - 400 mg to 800 mg IV infusion over 30 min every 6h prn
    • Fever - 400 mg every 4 to 6 hrs prn (can use lower doses)
new nsaids25
New NSAIDs
  • Diclofenac Potassium for Oral Solution (Cambia®)
    • Oral solution for acute migraine, get level within 5 min,max in 15 min
    • 50 mg dose, mix powder in 1-2 oz of water
    • Buy in a co-joined dose pack of three or a box of nine
  • Diclofenac (Zipsor®)
    • Liquid-filled capsule formulation for mild to moderate pain
pain ladder26
Pain Ladder

NSAID + Acetaminophen

NSAIDs

Acetaminophen or nonacetylated salicylates

Nonpharmacologic Approaches

pain ladder27
Pain Ladder

Tylenol #3 or Tramadol for Chronic pain

NSAID + Acetaminophen

NSAIDs

Acetaminophen or nonacetylated salicylates

Nonpharmacologic Approaches

the opiates
The Opiates
  • Narcotic agonist
    • Natural (opiates) - morphine, codeine
    • Semisynthetic (opioids) - hydromorphone, oxycodone
    • Synthetic (opioids) - fentanyl, methadone
  • Narcotic agonist/antagonist
    • Nalbuphine, butorphanol
  • Narcotic antagonist
    • Naloxone (Narcan®)
opioid allergy
Opioid Allergy?
  • True allergic and anaphylactic reactions are rare
    • Single case reports with meperidine, morphine and fentanyl
    • Most cases reported use of other medications likely to cause allergy
    • None documented cross-sensitivity with other opioids
  • Urtiacaria, pruritis, sneezing, and exacerbations of asthma are common
    • Opioids cause a histamine release… this is NOT an allergic reaction, only allergy-like symptoms!
    • Does this mean the patient is “cross-sensitive” to other opioids?
      • Naturally occurring and semi-synthetic are more potent histamine releasers than synthetic
      • Risk of cross-sensitivity is extremely low if at all
pharmacokinetics
Pharmacokinetics
  • Time to reach Cmax
    • PO, SL, PR 60 to 90 min
    • IM 30 min
    • SQ, IV 10 to 15 min
  • Duration of effect is somewhere around 3 to 5 hours for PO/PR
  • PO is generally weaker than IV/IM due to first-pass effect, ~3 to 5 times weaker
immediate release dosing
Immediate release dosing
  • Dose every 4 hours
    • PRN is OK for acute pain
  • Can adjust dose daily for chronic use
  • The exception is methadone, which is immediate release with a long half-life (more later).
sustained release dosing
Sustained-release dosing
  • Especially important for chronic pain management
  • Dosed every 8h, 12h, 24h, depending on the product and formulation.
  • Don’t crush or chew these
  • Adjust dose every 2 to 4 days
tylenol 3
Tylenol #3
  • Codeine 30 mg + acetaminophen
  • Chronic codeine causes lots of side effects:
    • Constipation
    • Urinary retention
  • Tylenol #2 contains 15 mg of codeine
  • Tylenol #4 contains 60 mg of codeine
  • Empirin with Codeine® (codeine and aspirin)
    • 325mg/30mg; 325mg/60mg
tramadol
Tramadol
  • Binary analgesic
  • Drug interactions with SSRI’s and TCA’s
    • Seizure risk?
  • Cross-sensitive allergy with codeine is possible
  • Regular release and extended release products (100 mg, 200 mg, 300 mg)
  • Combination with acetaminophen (Ultracet®)
new binary analgesic
New Binary Analgesic
  • Tapentadol (Nucynta®)
    • Strong narcotic (C-II) + NE reuptake inhibitor
      • Watch with look-alike Nuvigil® (armodafinil)
    • Analgesic for acute moderate to severe pain
    • Approved for those > 18 years of age
    • 50 mg, 75 mg, 100 mg tabs every 4-6 hrs prn
      • Dose the second dose as soon an hour after first dose if not relief
    • Tapentadol is metabolized, but there are no known interactions
    • No effect on QT elongation or other EKG parameters, even in combination with moxifloxacin (pkg insert)
pain ladder36
Pain Ladder

What’s in the basement?

Tylenol #3 or Tramadol

NSAID + Acetaminophen

NSAIDs

Acetaminophen or nonacetylated salicylates

Nonpharmacologic Approaches

pain ladder37
Pain Ladder

What’s in the basement?

Tylenol #3 or Tramadol

Darvocet®

NSAID + Acetaminophen

NSAIDs

Acetaminophen or nonacetylated salicylates

Nonpharmacologic Approaches

darvocet research observations
Darvocet Research Observations
  • Listed on the “Beer’s” list
    • Why?
  • Increase side effects from the metabolite norpropoxyphene
    • long half-life (36 hrs) and the risk of accumulation
  • Studies show no enhanced analgesic effects from the addition of propoxyphene to acetaminophen
propoxyphene products
Propoxyphene Products
  • Darvocet-N 50® (generic available)
    • 50 mg propoxyphene + 325 mg acetaminophen
  • Darvocet-N 100® (generic available)
    • 100 mg propoxyphene + 325 mg acetaminophen
  • Wygesic® Tablets (generic available)
    • 65 mg propoxyphene + 650 mg acetaminophen
  • New Product
    • Darvocet A500®
    • 100 mg propoxyphene + 500 mg acetaminophen
pain ladder40
Pain Ladder

Tylenol #3 + NSAID

Tylenol #3 or Tramadol

NSAID + Acetaminophen

NSAIDs

Acetaminophen or nonacetylated salicylates

Nonpharmacologic Approaches

pain ladder41
Pain Ladder

Hydrocodone combo

Tylenol #3 + NSAID

Tylenol #3 or Tramadol

NSAID + Acetaminophen

NSAIDs

Acetaminophen or nonacetylated salicylates

Nonpharmacologic Approaches

hydrocodone
Hydrocodone
  • Derivative of codeine
  • Many different products:
  • Lorcet 10mg/650 mg (acetaminophen)
  • Lorcet HD & Vicodin 5 mg/500 mg
  • Lorcet Plus 7.5 mg/650 mg
  • Lortab 2.5 mg/500mg, 5 mg/500 mg,

7.5 mg/500 mg, 10 mg/500 mg

  • Lortab Elixir 2.5 mg/167 mg per 5 ml
hydrocodone43
Hydrocodone
  • Vicodin 5 mg/500 mg
  • Vicodin ES 7.5 mg/750 mg
  • Vicodin HP 10 mg/660 mg
  • Vicoprofen 7.5 mg/200 mg
  • Zydone 5 mg/400 mg, 7.5 mg/400 mg
  • Norco 10 mg/325 mg
  • Anexsia 5 mg/325, 5/500, 7.5/325, 7.5/650
  • Maxidone 10 mg/750 mg (max of 5 tabs a day)
pain ladder44
Pain Ladder

Oxycodone or

Oxymorphone

Hydrocodone or combo

Tylenol #3 + NSAID

Tylenol #3 or Tramadol

NSAID + Acetaminophen

NSAIDs

Acetaminophen or nonacetylated salicylates

Nonpharmacologic Approaches

oxycodone
Oxycodone
  • Percodan® contains aspirin
  • Percocet® contain acetaminophen
  • Combunox®
    • (oxycodone 5 mg + ibuprofen 400 mg)
  • Lots of new Percocet® products:
    • 2.5 mg/325 mg
    • 7.5 mg/325 mg, 7.5 mg/500 mg
    • 10 mg/325 mg, 10 mg/650 mg
  • Tylox® 5mg/500 mg
  • Oxycontin®: 10 mg, 20 mg, 40 mg, 80 mg, 160 mg
immediate release oxycodone
Immediate-release oxycodone
  • Oxycodone or Roxicodone
  • Tablets - 5 mg, 15 mg, 30 mg
  • Capsules - 5 mg
  • Oral solution - 5 mg/5 ml
  • Concentrate - 20 mg/ml
new cii for pain
New CII for Pain
  • Oxymorphone
      • Semi-synthetic metabolite of oxycodone
      • Long-acting formulations not for opioid-niave patients; standard dose determined from previous opioid dose
    • Opana® - oxymorphone - 5 mg ($2.40 per tab) , 10 mg ($4.30 per tab)
      • Dose 10 to 20 mg every 4-6 hours prn
    • Opana ER® - oxymorphone - 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg ($11 per tab), given every 12 hours
    • 10 mg oxymorphone = 20 mg hydrocodone, 20 mg oxycodone, 20 mg methadone, 30 mg oral morphine
pain ladder48
Pain Ladder

Morphine

Oxycodone or

Oxymorphone

Hydrocodone or combo

Tylenol #3 + NSAID

Tylenol #3 or Tramadol

NSAID + Acetaminophen

NSAIDs

Acetaminophen or nonacetylated salicylates

Nonpharmacologic Approaches

morphine products
Morphine products
  • Sustain-release
    • MS-Contin®
      • 15 mg, 30 mg, 60 mg, 100 mg, 200 mg
    • Avinza® once daily
      • 30 mg, 60 mg, 90 mg, 120 mg
    • Kadian® once daily
      • 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, 200 mg capsule
    • DepoDur® (morphine extended release, epidural)
  • Immediate-release
    • Tablets
    • Oral solution 10 mg/5 ml, 20 mg/5ml, 20mg/ml
    • Supp: 5 mg, 10 mg, 20 mg, 30 mg
slide50

New CII for Pain

  • Morphine/naltrexone (Embeda®)
    • 24 hour analgesic for moderate to severe pain
      • Can give daily or twice daily
    • Extended-release capsule, not “prn” medication
    • 20mg/0.8mg, 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg, 100 mg/4 mg
pain ladder51
Pain Ladder

Hydromorphone

Ladder Extension

hydromorphone products
Hydromorphone products
  • Dilaudid tablets
    • 1 mg, 2 mg, 3 mg, 4 mg, 8 mg
  • Extended release formulation - Exalgo®
    • For chronic pain
  • Liquid
    • 5 mg/5 ml
  • Injection
    • 1 mg, 2 mg, 4 mg, 10 mg per ml
  • Suppositories
    • 3 mg
  • Dilaudid cough syrup
    • 1 mg/5 ml; + 100 mg guaifenesin
pain ladder53
Pain Ladder

Fentanyl

Hydromorphone

Ladder Extension

fentanyl products
Fentanyl Products
  • Injection
    • 0.05 mg/ml
  • Transmucosal (Fentanyl Oralet®, Actiq®)
    • Oralet®-100 mcg, 200 mcg, 300 mcg, 400 mcg
    • Actiq® - 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, 1600 mcg
  • Transdermal
    • Duragesic® -12 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg
transdermal fentanyl
Transdermal Fentanyl
  • C max = 24 hours
  • Patch last 48 to 72 hours
  • Watch if used on skinny folks
    • need fat to absorb it predictably
  • Do not use in opiate naive patients.
    • 25 mcg patch is ~50 mg IR morphine per day
  • Watch in patients with fever, use of heating pad, blankets, hot tubs, etc.
new fentanyl product
New Fentanyl Product
  • Fentanyl (Onsolis®)
    • Buccal soluble film formulation for rescue cancer pain
    • 200, 400, 600, 800, 1200 mcg
    • No more than 4 doses per day
    • Separate by at least 2 hours
    • Patient has to enroll into the FOCUS program
    • Get medication from a special pharmacy