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Pharmacotherapeutic Options in Pain Management. Charles E. Argoff, M.D. Director, Cohn Pain Management Center North Shore University Hospital Assistant Professor of Neurology New York University School of Medicine. Characteristic Acute Pain Chronic Pain Cause Generally known Often unknown

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Pharmacotherapeutic options in pain management l.jpg

Pharmacotherapeutic Options in Pain Management

Charles E. Argoff, M.D.

Director, Cohn Pain Management Center

North Shore University Hospital

Assistant Professor of Neurology

New York University School of Medicine


Acute vs chronic pain l.jpg

Characteristic Acute Pain Chronic Pain

Cause Generally knownOften unknown

Duration of pain Short, Persists after well-characterized healing, 3 mo

Treatment Underlying disease Underlying disease approach and pain disorder

Acute vs Chronic Pain


Nociceptive vs neuropathic pain l.jpg
Nociceptive vs Neuropathic Pain

Nociceptive

Pain

Caused by activity in neural pathways in response to potentially tissue-damaging stimuli

MixedType

Caused by a combination of both primary injury or secondary effects

Neuropathic Pain

Initiated or caused by primary lesion or dysfunction in the nervous system

CRPS*

Postherpeticneuralgia

Postoperativepain

Trigeminalneuralgia

Arthritis

Sickle cellcrisis

Neuropathic low back pain

Mechanicallow back pain

Central post-stroke pain

Distalpolyneuropathy (eg, diabetic, HIV)

Sports/exerciseinjuries

*Complex regional pain syndrome


Potential descriptions of chronic pain l.jpg

Sensations

burning

paresthesia

paroxysmal

lancinating

electriclike

raw skin

shooting

deep, dull, bonelike ache

Cardinal signs/symptoms

allodynia: pain from a stimulus that does not normally evoke pain

thermal

mechanical

hyperalgesia: exaggerated response to a normally painful stimulus

Potential Descriptions of Chronic Pain


Pathophysiology of chronic pain l.jpg
Pathophysiology of Chronic Pain

  • Chemical excitation of nonnociceptors

  • Recruitment of nerves outside of site of injury

  • Excitotoxicity

  • Sodium channels

  • Ectopic discharge

  • Deafferentation

  • Central sensitization

    • maintained by peripheral input

  • Sympathetic involvement

  • Antidromic neurogenic inflammation


Pathophysiology peripheral sensitization l.jpg
Pathophysiology:Peripheral Sensitization

Nociceptor

Nociceptor

Na+channels

Innocuousstimulus

Painsensation

  • Adapted from Woolf CJ et al. Lancet. 1999;353:1959-1964.


Pathophysiology central sensitization l.jpg
Pathophysiology:Central Sensitization

Normal sensory function

Ab fibermechanoreceptor

Weaksynapse

Nonpainfulsensation

Innocuousstimulus

Na+channel

Na+channel

Increased nociceptor drive leads to central sensitization of dorsal horn neurons

Increasedsynapsisstrength

Painfulsensation

Innocuousstimulus

Na+channel

Na+channel

  • Adapted from Woolf CJ et al. Lancet. 1999;353:1959-1964.


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Pathophysiology:Peripheral and Central Sensitization



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Assessment of Pain Intensity

Visual Analog Scale

Verbal Pain Intensity Scale

No Mild Moderate Severe Very Worst pain pain pain pain severe possible pain pain

Worstpossiblepain

No

pain

0–10 Numeric Pain Intensity Scale

Faces Scale

0 1 2 3 4 5 6 7 8 9 10

No Moderate Worst pain pain possible pain

0 1 2 3 4 5

Portenoy RK, Kanner RM, eds. Pain Management: Theory and Practice. FA Davis; 1996:8-10. Wong DL. Waley and Wong’s Essentials of Pediatric Nursing. 5th ed. Mosby, Inc.; 1997:1215-1216. McCaffery M, Pasero C. Pain: Clinical Manual. Mosby, Inc. 1999:16.

21


Assessment of pain intensity12 l.jpg
Assessment of Pain Intensity

Visual Analog Scale

Verbal Pain Intensity Scale

No Mild Moderate Severe Very Worst pain pain pain pain severe possible pain pain

Worstpossiblepain

No

pain

0–10 Numeric Pain Intensity Scale

Faces Scale

0 1 2 3 4 5 6 7 8 9 10

No Moderate Worst pain pain possible pain

0 1 2 3 4 5

Portenoy RK, Kanner RM, eds. Pain Management: Theory and Practice. FA Davis; 1996:8-10. Wong DL. Waley and Wong’s Essentials of Pediatric Nursing. 5th ed. Mosby, Inc.; 1997:1215-1216. McCaffery M, Pasero C. Pain: Clinical Manual. Mosby, Inc. 1999:16.

21


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Multidisciplinary Treatment of Chronic Pain

  • Pharmacotherapy and other medical/surgical care with appropriate medicine reorganization

  • Restorative care including active physical and occupational therapy

  • Psychological counseling utilizing cognitive-behavioral pain management strategies


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Aim for Monotherapy

Titrate only one drug at a time


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PharmacotherapyGuidelines

  • Medication must result in:

    • Significant pain relief

    • Tolerable side effects

function


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Pharmacotherapy Guidelines

  • Both physician & patient must realize significant individual variability


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Pharmacotherapy Guidelines

  • Slow titration until either:

    • Significant pain relief

    • Intolerable side effects

    • “Toxic serum level”


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Pharmacotherapy Guidelines

  • Educate the patient


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Non-Opiate Pharmacotherapy

  • NSAIDs/Cox-2

  • Acetaminophen

  • Antidepressants

  • Anticonvulsants

  • Oral local anesthetics

  • Alpha adrenergic agents

  • Neuroleptics

  • NMDA receptor antagonists

  • Muscle relaxants

  • Topical analgesics

  • Emerging Agents


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Non-Opiate Pharmacotherapy

  • NSAIDs/Cox-2

  • Acetaminophen

  • Antidepressants

  • Anticonvulsants

  • Oral local anesthetics

  • Alpha adrenergic agents

  • Neuroleptics

  • NMDA receptor antagonists

  • Muscle relaxants

  • Topical analgesics

  • Emerging Agents


Non opiate pharmacotherapy21 l.jpg
Non-Opiate Pharmacotherapy

  • NSAIDs/Cox-2

  • Acetaminophen

  • Antidepressants

  • Anticonvulsants

  • Oral local anesthetics

  • Alpha adrenergic agents

  • Neuroleptics

  • NMDA receptor antagonists

  • Muscle relaxants

  • Topical analgesics

  • Emerging Agents




Non opiate pharmacotherapy24 l.jpg
Non-Opiate Pharmacotherapy

  • NSAIDs/Cox-2

  • Acetaminophen

  • Antidepressants

  • Anticonvulsants

  • Oral local anesthetics

  • Alpha adrenergic agents

  • Neuroleptics

  • NMDA receptor antagonists

  • Muscle relaxants

  • Topical analgesics

  • Emerging Agents


Non opiate pharmacotherapy25 l.jpg
Non-Opiate Pharmacotherapy

  • NSAIDs/Cox-2

  • Acetaminophen

  • Antidepressants

  • Anticonvulsants

  • Oral local anesthetics

  • Alpha adrenergic agents

  • Neuroleptics

  • NMDA receptor antagonists

  • Muscle relaxants

  • Topical analgesics

  • Emerging Agents


Anticonvulsants l.jpg

Carbamazepine*

Divalproex sodium*

Gabapentin

Clonazepam

Phenytoin

*Has FDA indication for pain/headache

Lamotrigine

Topiramate

Zonisamide

Oxcarbazepine

Levatriacetam

Tiagabine

Anticonvulsants


Anticonvulsant drugs and neuropathic pain disorders l.jpg

Postherpetic neuralgia

gabapentin

Diabetic neuropathy

carbamazepine

phenytoin

gabapentin

lamotrigine

HIV-associated neuropathy

lamotrigine

Trigeminal neuralgia

carbamazepine

lamotrigine

oxcarbazepine

Central poststroke pain

lamotrigine

Anticonvulsant Drugs and Neuropathic Pain Disorders*

*Not approved by FDA for this use.

43


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Gabapentin in the Treatment of Painful Diabetic Neuropathy*

10

Placebo

Gabapentin

8

N=165

6

Mean pain score

4

2

†P<0.01; ‡P<0.05.

0

Screening

1

2

3

4

5

6

7

8

Week

*Not approved by FDA for this use.

Adapted from Backonja M et al. JAMA. 1998;280:1831-1836.

46


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Non-Opiate Pharmacotherapy

  • NSAIDs/Cox-2

  • Acetaminophen

  • Antidepressants

  • Anticonvulsants

  • Oral local anesthetics

  • Alpha adrenergic agents

  • Neuroleptics

  • NMDA receptor antagonists

  • Muscle relaxants

  • Topical analgesics

  • Emerging Agents


Non opiate pharmacotherapy30 l.jpg
Non-Opiate Pharmacotherapy

  • NSAIDs/Cox-2

  • Acetaminophen

  • Antidepressants

  • Anticonvulsants

  • Oral local anesthetics

  • Alpha adrenergic agents

  • Neuroleptics

  • NMDA receptor antagonists

  • Muscle relaxants

  • Topical analgesics

  • Emerging Agents



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Possible Effective Uses of Tizanidine

  • Trigeminal neuralgia (Fromm 1993)

  • Chronic low back pain(Berry 1988)

  • Cluster headache (D’alessandro 1996)

  • Chronic tension-type headache (Nakashima 1994)

  • Spasmodic torticollis (Houten 1984)

  • Neuropathic pain

  • Chronic headache(2002)


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Efficacy of Tizanidine in Neuropathic Pain: An Open-Label StudyMarilyn R. Semenchuk, PharmD, BCPP; Scott Sherman, MDUniversity of Arizona, Neurology Clinic

  • Trial Design:

    • Open-label (N=22)

      • 14 peripheral neuropathy, 1 diabetic neuropathy, 3 reflex sympathetic dystrophy, 1 radiculopathy, 2 nerve damage, 1 trigeminal neuralgia

    • 8 week treatment duration

    • Zanaflex initiated at dose of 4 mg qd hs for 7 days and increased by 2 mg – 8 mg weekly and taken in divided doses up to three time a day

    • The dose was escalated to the patient’s effective or maximum tolerated dose or a maximum of 36 mg/day


Slide34 l.jpg

Efficacy of Tizanidine in Neuropathic Pain: An Open-Label StudyMarilyn R. Semenchuk, PharmD, BCPP; Scott Sherman, MDUniversity of Arizona, Neurology Clinic

  • Outcome Measures:

    • Mean average weekly pain rating from patient diary (VAS)

    • Biweekly patient global assessment of pain relief

    • Mean biweekly scores of Neuropathic Pain Scale

    • Mean biweekly scores on the Wisconsin Brief Pain Inventory


Slide35 l.jpg

Efficacy of Tizanidine in Neuropathic Pain: An Open-Label StudyMarilyn R. Semenchuk, PharmD, BCPP; Scott Sherman, MDUniversity of Arizona, Neurology Clinic

  • Results:

    • Zanaflex may be an effective treatment of neuropathic pain in many patients and is generally well tolerated, offering an alternative for patients unable to tolerate other medication

    • The mean effective or maximum tolerated dose was 23 mg/day, the median dose was 24 mg/day and the dose range was 6 – 36 mg/day

    • Inhibition of the synaptic transmission of nociceptive stimuli in the spinal pathways may mediate this effect


Slide36 l.jpg

Efficacy of Tizanidine in Neuropathic Pain: An Open-Label StudyMarilyn R. Semenchuk, PharmD, BCPP; Scott Sherman, MDUniversity of Arizona, Neurology Clinic


Non opiate pharmacotherapy37 l.jpg
Non-Opiate Pharmacotherapy

  • NSAIDs/Cox-2

  • Acetaminophen

  • Antidepressants

  • Anticonvulsants

  • Oral local anesthetics

  • Alpha adrenergic agents

  • Neuroleptics

  • NMDA receptor antagonists

  • Muscle relaxants

  • Topical analgesics

  • Emerging Agents


Non opiate pharmacotherapy38 l.jpg
Non-Opiate Pharmacotherapy

  • NSAIDs/Cox-2

  • Acetaminophen

  • Antidepressants

  • Anticonvulsants

  • Oral local anesthetics

  • Alpha adrenergic agents

  • Neuroleptics

  • NMDA receptor antagonists

  • Muscle relaxants

  • Topical analgesics

  • Emerging Agents


Advances in opioid analgesia l.jpg

Nerve Injury

Mu-Opioid-RActivation

NMDA-R

PKC

Inhibitors

 Excitability

Neurotoxicity

 Mu-Efficacy

Hyperalgesia

Mu-Opioid Tolerance

Advances in Opioid Analgesia


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Drugs with Potential NMDA-R Antagonist Properties

  • Dextromethorphan

  • Ketamine

  • d-Methadone

  • Amantadine

  • Memantine

  • Amitriptyline


Dextromethorphan postherpetic neuralgia painful diabetic neuropathy l.jpg
DEXTROMETHORPHANPostherpetic Neuralgia & Painful diabetic neuropathy

  • 2 RCTs Crossover: 6 weeks

    • Dextromethorphan alone vs placebo

  • DN:

    • mean daily dose = 381 mg/day

    • Pain decreased ( p=0.01)

  • PHN:

    • mean daily dose = 439 mg/day

    • Did not significantly reduce pain

      (Nelson 1997)


Non opiate pharmacotherapy42 l.jpg
Non-Opiate Pharmacotherapy

  • NSAIDs/Cox-2

  • Acetaminophen

  • Antidepressants

  • Anticonvulsants

  • Oral local anesthetics

  • Alpha adrenergic agents

  • Neuroleptics

  • NMDA receptor antagonists

  • Muscle relaxants

  • Topical analgesics

  • Emerging Agents


Muscle relaxants l.jpg
Muscle Relaxants

  • Cyclobenzaprine (Flexeril®)

  • Carisoprodol (Soma®)

  • Methocarbamol (Robaxin®)

  • Metaxalone (Skelaxin®)

  • Orphenadrine citrate (Norflex®)


Cyclobenzaprine l.jpg
Cyclobenzaprine

  • Structurally similar to tricyclics

  • Centrally acting

  • Nocturnal muscle spasm effects

  • Side effects:

    • Drowsiness - Cardiac dysrhythmias

    • Anticholinergic

      • Dry mouth

      • Blurred vision

      • Urine retention

      • Constipation

      • Increased intraocular pressure


Carisoprodol l.jpg
Carisoprodol

  • Precursor of meprobamate

  • Centrally active

  • Reduction of muscle spasm

  • Side effects:

    • Sedation, drowsiness, dependence

    • Withdrawal symptoms

      • Agitation

      • Anorexia

      • N/V

      • Hallucination

      • Seizures


Methocarbamol l.jpg
Methocarbamol

  • Investigative usage: MS

  • Daily dosage: 1000 mg qid

  • Side effect: drowsiness

  • Mechanism of action:

    • Centrally active

    • Inhibits polysynaptic reflexes

  • Clinical effects:

    • Reduction of muscle spasms


Metaxalone l.jpg
Metaxalone

  • Daily dosage: 400-800 mg tid

  • Clinical effects:

    • Reduction in muscle spasm

  • Side effects:

    • Nausea

    • Drowsiness

    • Dizziness


Orphenadrine citrate l.jpg
Orphenadrine Citrate

  • Investigative usage: SCI

  • Daily dosage: 100 mg bid

  • Analog of diphenhydramine

  • Given IV for antispasticity trials

  • Side effects:

    • Anticholinergic

    • Rare aplastic anemia


Non opiate pharmacotherapy49 l.jpg
Non-Opiate Pharmacotherapy

  • NSAIDs/Cox-2

  • Acetaminophen

  • Antidepressants

  • Anticonvulsants

  • Oral local anesthetics

  • Alpha adrenergic agents

  • Neuroleptics

  • NMDA receptor antagonists

  • Muscle relaxants

  • Topical analgesics

  • Emerging Agents


Topical analgesics key facts l.jpg
Topical Analgesics: Key Facts

  • Topical agents are active within the skin, soft tissues and peripheral nerves.

  • In contrast to transdermal, oral or parenteral medications, use of a topical agent does not result in clinically significant serum drug levels.

  • Other benefits include lack of systemic side effects and drug-drug interactions.

  • The mechanism of action of a topical analgesic is unique to the specific agent considered.


Topical treatments for chronic pain l.jpg
Topical Treatments for Chronic Pain

  • Aspirin preparations

    • eg, aspirin in chloroform or ethyl ether

  • Capsaicin

  • Local anesthetics

    - lidocaine patch 5%/eutectic mixture of local anesthetics

  • Tricyclic antidepressants

  • Opiates

  • Investigational agents


Capsaicin l.jpg
Capsaicin

  • Neuropathic pain states studied include: diabetic neuropathy, PHN, post-mastectomy pain, HIV neuropathy.

  • Non-neuropathic pain states such as osteoarthritis have been studied as well.

  • Efficacy demonstrated in some of these studies but limited by adverse effects and compliance issues.

  • New formulations are being studied.


Topical lidocaine patch 5 l.jpg
Topical Lidocaine Patch 5%

  • Lidocaine 5% in pliable patch

  • Up to 3 patches applied once daily directly over painful site

    • 12 h on, 12 h off(FDA-approved label)

    • recently published data indicate 4 patches(18–24h) safe

  • Efficacy demonstrated in 3 randomized controlled trials in postherpetic neuralgia

  • Systemic side effects unlikely

    • most common side effect: application-site sensitivity

  • Clinically insignificant serum lidocaine levels

  • Mechanical barrier may decrease allodynia


Slide54 l.jpg
EMLA®

  • EMLA®: not FDA approved for any specific neuropathic pain state

  • One controlled study of use of EMLA® in the treatment of PHN demonstrated equal efficacy with placebo

  • Several uncontrolled studies have supported the use of EMLA® in PHN


Topical local anesthetics for non neuropathic pain states l.jpg
Topical Local Anesthetics for Non-Neuropathic Pain States

  • Low back pain

  • Osteoarthritis

  • Chronic myofascial pain

  • Acute soft tissue injury pain

  • Post-operative pain


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Topical Opiates

  • 1.     Galeotti N, DeCesare Mannelli L, Mazzanti G, et al. Menthol: a natural analgesic compound. Neurosci Lett 2002 Apr 12;322(3):145-148. This article is particularly interesting as the authors review evidence which suggests that one of the mechanisms of analgesia for menthol, a common ingredient in over the counter preparations may actually be the activation of kappa opiate receptors.


Topical morphine treatment in cancer related pain l.jpg
Topical Morphine Treatment in Cancer-Related Pain

  • Effect of topical morphine for mucositis-associated pain following concomitant chemoradiotherapy for head and neck carcinoma. (Cerchietti LC, Navigante AH, Bonomi MR, et al., Cancer 2002 Nov 15;95(10): 2230-6.)Patients (n=26) with cancer-related mucositis treated with topical morphine or topical lidocaine/diphenhydramine/magnesium topical solution.


Non opiate pharmacotherapy58 l.jpg
Non-Opiate Pharmacotherapy

  • NSAIDs/Cox-2

  • Acetaminophen

  • Antidepressants

  • Anticonvulsants

  • Oral local anesthetics

  • Alpha adrenergic agents

  • Neuroleptics

  • NMDA receptor antagonists

  • Muscle relaxants

  • Topical analgesics

  • Emerging Agents


Emerging analgesics l.jpg
Emerging Analgesics

  • Botulinum Toxin (Type A, Type B)

  • New intraspinal agents

  • Thalidomide

  • Topical antidepressants


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Opiate Pharmacotherapy

  • Special issues

  • Evidence for efficacy


The new millennium l.jpg
The New Millennium

  • Era of “Balance”

  • Growing recognition that opioids are essential for chronic pain

  • DEA, FDA, Federation of State Medical Boards, APS, AAPM, ASAM, ACR, AGS

    • all issue guidelines supporting appropriate use of opioids for chronic pain

  • Potential risks are serious but can be managed

  • The goal: maximize symptom relief and functional improvement while minimizing addiction, diversion, and side effects

6


What types of pain may respond to opioids l.jpg
What Types of Pain MayRespond to Opioids?

  • Categories

    • acute pain

    • cancer pain

    • chronic (persistent) noncancer pain

  • Temporal pattern

    • episodic/continuous

  • Mechanisms

    • nociceptive (somatic or visceral)

    • neuropathic (peripheral or central)

9


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Acute Pain Management: Continuing Treatment Challenges

  • Clinical lore to the contrary, acute postoperative pain is poorly controlled.

  • Persistent acute pain may have harmful physiological and psychological effects.

  • Agency for Health Care Policy and Research guidelines for treatment of moderate to severe postoperative pain recommend opioid analgesics.

13


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Categories of Opioid Drugs

  • Short-acting opioids

    • morphine sulfate (eg, Roxanol™, MSIR®)

    • codeine

    • hydrocodone (eg, Zydone®, Vicodin®, Lortab®, Vicoprofen®)*

    • oxycodone (eg, Roxicodone™, Oxy IR®, Percocet®, Tylox®, Percodan®)*

    • hydromorphone (Dilaudid®)

    • oxymorphone (Numorphan®)

    • fentanyl (Actiq®)

* May contain additional active ingredient.

16


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Categories of Opioid Drugs (cont)

  • Long-acting opioids

    • methadone

    • sustained-release morphine (eg, MS Contin®, Avinza™; Kadian®, Oramorph®)

    • sustained-release oxycodone (Oxycontin®)

    • transdermal fentanyl (Duragesic®)

17


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Opioids in Chronic Pain: Review of Randomized, Controlled Clinical Trials

  • Efficacy of opioids in chronic noncancer pain established in a number of randomized, controlled trials, including placebo-controlled trials of:

    • codeine

    • tramadol

    • oxycodone

    • morphine

    • fentanyl

  • Comparative trial of transdermal fentanyl and sustained-release oral morphine

18


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Assessing and Documenting Treatment Outcomes Clinical Trials

The “Four A’s of Pain”

  • analgesia

  • activities of daily living

  • adverse effects

  • aberrant drug-taking behaviors

20


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Reassessment: Clinical Trials The Importance of Follow-up

Continual follow-up and monitoring are essential to good opioid analgesic therapy.

  • Reassess the “Four A’s of Pain”

    • analgesia

    • activities of daily living

    • adverse effects

    • aberrant drug-taking behaviors

  • Review treatment options

33


Management of opioid side effects l.jpg
Management of Opioid Side Effects Clinical Trials

  • Nausea and vomiting

    • switch opioids; anti-emetics

  • Sedation

    • lower dose if possible; add co-analgesics; add stimulants

  • Constipation

    • treat prophylactically with stool softeners, bowel stimulants, and nonpharmacologic measures; switch opioids

34


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Management of Opioid Side Effects Clinical Trials (cont)

  • Itching

    • switch opioids; antihistamines

  • Endocrine dysfunction/decrease in libido

    • switch opioids; endocrine monitoring; testosterone replacement; endocrine consultation

  • Addiction

    • refer for comprehensive assessment

35


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Distinguishing Dependence, Tolerance, and Addiction Clinical Trials

  • Physical dependence: a withdrawal syndrome would arise if a drug is discontinued, dose is substantially reduced, or antagonist is administered

  • Tolerance: a greater amount of drug is needed to maintain therapeutic effect, or loss of effect over time

  • Pseudoaddiction: behavior suggestive of addiction caused by undertreatment of pain

  • Addiction (psychological dependence): a psychiatric disorder characterized by continued compulsive use of a substance despite harm

36


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Summary Clinical Trials

  • Numerous pharmacotherapeutic options are available for the management of chronic pain.

  • Proper evaluation including pain assessment is key to providing the best analgesic approach.

  • Optimizing analgesia in the long term care setting requires achieving a proper balance among efficacy, adverse effects, cost and other factors.


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