Migrainefinal

P R E S C R I B I N G G U I D E L I N E S F O R P R I M A RY C A R E C L I N I C I A N S
THERAPEUTIC
A
MIGRAINE
SSESSMENT
First Published 1998. Revised 2002
Rational Use of Opioids in Chronic or Recurrent Non-malignant Pain
Background
The recommendations are based on the best available evidence, although it is recognised mild headache and evolve in severity over population. It is a source of major distress, time. If the headache evolves during sleep, disability and absenteeism from both paid migraine and its treatment is still evolving.
then headache may be intense on waking.
The aim of management of an acute attack migraine usually involves the administration noted against each treatment to assist in of migraine is to terminate the attack as soon of specific anti-migraine drugs rather than the interpretation and implementation of the as possible after its onset, preferably before analgesics alone and certainly the use of guideline in your individual practice (see table).
Approach
stepwise. It should be based on the patient’s A review of authorities issued for opioid use previous experience, severity and duration of management is required. Non-pharmacological for chronic non malignant pain found that the headache and any associated symptoms.
Over the course of multiple attacks, many were for migraine,2 even though this is an patients with migraine will identify from inappropriate choice of analgesic for most their own experience the agent of greatest an integral part of migraine management. patients and should have an extremely limited efficacy for managing their acute attacks. It assumes that a diagnosis of migraine has role. Opioids are often prescribed for patients In subsequent attacks, that agent should be been established. In some patients, however, with social problems, high levels of emotional employed at the very first hint of migraine, distress and unclear medical diagnoses.
ie when the attack is mild. Failure to use an transform into predominantly non-migraine Rather than treating the complaint of migraine effective treatment promptly may increase pain, headache. The diagnosis of migraine therefore effectively, doctors appear to be responding disability and the impact of the headache.5 needs to be reassessed over time and if not to patients’ frustration and distress. the current predominant diagnosis, this needs In addition to prescription of medications, The use of short acting injectable opioids the management of migraine involves patient is a particular problem, as escalation of opioid education. The patient’s active participation use (and accompanying increase in pain and dysfunction) is common in people treated reflect the ways in which patients present in outcomes of therapeutic intervention. It is general practice and should assist with acute important that the aims and expectations management of patients who suffer frequent Escalation of opioid use is common in people of any therapeutic intervention are explained taking short-acting opioids, as they reinforce drug seeking behaviours. This presents the general practitioner with the dual problem of prophylactic therapy that such patients may inadequate management of migraine and the prophylaxis, refer to Therapeutic Guidelines:Neurology (Version 2, 2002).9 A number of Several guidelines4-9 have been produced to relevant reviews have also been published.10-12 assist clinicians to manage pain associatedwith migraine. The purpose of this documentis to integrate the key points from theseguidelines with practice based experiencefrom general practitioners. Funded by
General Points
Is there a place for opioids in
If all else fails.
migraine management?
In very rare episodes the general practitioner triptans are minor and head to head trials are limited. What seems to matter most are The Australian Association of Neurologists opioid such as morphine is required in that naratriptan may be less effective than other randomised controlled trials have concluded triptans at standard doses17. If patients do not contemplated for patients known personally respond to one triptan, they may respond to one of the others, or to an alternative route non-steroidal anti-inflammatory drug (NSAID).4 should be advised of the relatively short of administration. A critical appraisal of the Pethidine is short acting compared with the triptans is provided in a recent review by potential for dependence. An escalation of opioid dose or administration frequencyshould be cause for reassessment in regard In a randomised controlled trial it was found that the combination of aspirin (900 mg) and paracetamol has been shown to be similar metoclopramide (10 mg) was as effective as in efficacy to aspirin alone for relief of pain in made with an appropriate specialist for early sumatriptan in the treatment of migraine and migraine.13 The addition of codeine (30-60mg) advice. The patient should be referred to a was better tolerated.19 It is also significantly specialist in drug dependence or a specialist less expensive. A recent systematic review17 be better than paracetamol alone in relieving non-migraine pain, but the magnitude of this suspected. If early referral is not practical, was more effective than aspirin (900mg) and difference is small (approximately 5%).14 advice can usually be obtained by telephone. metoclopramide (10mg) at 2 hours, but that The profound delaying effect of codeine on gastric emptying generally precludes its use For clinical advice on the management of a patient with problems related to opioiddependence, call the NSW Drug and Alcohol When not to use triptans
Specialist Advisory Service on 1800 023 687 or ergotamine
Ergotamine, dihydroergotamine and triptans non-randomised blinded study in 25 patients suspected to have ischaemic heart disease, there is any information on a patient seeking other vascular disease or poorly controlled hypertension. Triptans should be used with seeing other doctors or obtaining multiple caution in patients on lithium, monoamine oxidase inhibitors or SSRIs, because of the limitations to the value of such information (eg it may not be current or comprehensive).
Is a there a place for NSAIDs in
When to use a triptan
migraine management?
NSAIDs are a reasonable first line treatment are available in Australia for the treatment of choice for mild to moderate acute attacks migraine (naratriptan, sumatriptan, zolmitriptan).
Tramadol is a centrally active analgesic All have similar efficacy and side effects.
with opioid-like effects. It appears to act by responsive in the past to NSAIDs,5 and are Sumatriptan has the advantage of multiple modifying transmission of pain impulses via comparable with oral sumatriptan in terms dosage forms (oral, nasal spray and injection).
inhibition of noradrenaline and serotonin of efficacy, onset of analgesic effect and Triptans may not be effective if taken during tolerability.20 However, NSAIDs (including COX- 2 inhibitors) must be used with caution in the commences. Triptans must not be combined
available and is included in Doctors’ Bag elderly, in patients who are volume depleted with ergotamine containing preparations.
stocks. Although its efficacy in acute and and in patients with renal dysfunction or a To prevent progression of an acute migraine chronic pain is established, its efficacy in episode, a single oral dose of sumatriptan Ketorolac is an effective NSAID analgesic used with caution in patients on monoamine which can be administered by injection and and the patient assessed for response.
may be used for patients who cannot tolerate Alternatively, sumatriptan may be given initially oral agents. Intramuscular ketorolac has been because such combinations may precipitate by subcutaneous injection (6 mg) or nasal spray (10-20mg) and the patient reassessed before additional doses are given. If headache does not respond, no further doses should be given (neither should ergotamine preparations be used for at least 6 hours). If the headacheresponds but recurs, further doses may be given - up to a total daily dose of sumatriptan rofecoxib) may reduce the risk of serious 300 mg orally, 40mg intranasally, or 12 mg gastrointestinal adverse events,23, 24 they are no more effective than traditional NSAIDs.
They should be reserved for patients at highrisk for upper GI bleeding.
Changing from a triptan to
Chlorpromazine
Two studies have compared prochlorperazine ergotamine or vice versa
The mechanism of action of chlorpromazine and metoclopramide as single agents fortreatment of acute migraine.30, 31 A triptan should not be used if ergotamine in migraine is uncertain, but may involve a Prochlorperazine provided better pain and has been used in the previous 24 hours.
combination of its anti-serotonergic effect, nausea relief than metoclopramide but rescue Ergotamine should not be used if a triptan anti-dopaminergic effect in the chemoreceptor analgesic therapy was often necessary.
has been used in the previous 6 hours.
trigger zone and vascular effects through its alpha-blocking action. Because of its Neither drug can therefore be recommendedas a single agent therapy for migraine. Over the counter (OTC) preparations
and complementary medicines
occasionally dystonia, parenteralchlorpromazine should only be administered drugs in combination with an analgesic or Many patients buy preparations from their in a monitored environment where patients pharmacy or supermarket in order to treat can be regularly observed and assessed.
migraine. It is important to ask the patient Intranasal therapy for migraine
about any non-prescribed drug use to ensure measured before and monitored closely after injection. Note that intramuscular injection has been associated with development of sterile been evaluated in clinical trials, although only sumatriptan is marketed as an intranasal preparation in Australia. Intranasal sumatriptan Analgesic rebound headache and
was found to be more effective than placebo medication overuse headache
in two studies.32 Partial headache relief Although feverfew (Tanacetum parthenium L.) was achieved in 40-60% of patients treated Medication overuse headache (drug-induced with sumatriptan versus 29-35% of patients prophylaxis of migraine,25 there have been treated with placebo.32 Intranasal sumatriptan no published trials in treatment of acute appears to have the same efficacy as oral episodes. Similarly, while acupuncture has sumatriptan, but a quicker onset of action.33 caffeine, especially when patients use acute prophylaxis,26 its value for analgesia during Migraine in pregnancy
week.29 It may also occur with antihistamines,opioids, anti-migraine nasal sprays and Although there is no clear evidence, it is migraine do not experience migraine during triptans).29 The character of the headache may pregnancy and should not require treatment between triptans and the herbal remedy St be indistinguishable from the original headache.
after the first trimester. However should John’s wort (Hypericum perforatum), which Patients exhibit escalating medication use may result in an increase in side effects.
with increasing frequency and intensity of adequate hydration (as it is with non pregnant patients) and intravenous rehydration should Dealing with refractory cases or
made before medication is withdrawn.
be considered early.9 Should medication with status migrainosus
Cessation will lead to withdrawal headaches with increased frequency. This requires careful ineffective, the patient may require referral to Status migrainosus should be managed in the hospital setting. Rehydration with intravenous therapy including sedation under observation.
fluids is usually required and parenteral Triptans and ergotamine should not be used Prochlorperazine or metoclopramide
Intravenous lignocaine
for nausea and vomiting
The Tfelt-Hansen study19 provides the basis for the aspirin-metoclopramide combination advocated for severe persistent migraine. Although there is reasonable evidence for itsuse in the more chronic pain setting, evidencesupporting efficacy in migraine is lacking. Relative cost of medicines
A randomised double-blind trial comparing (The following cost structures are provided for the information of doctors and patients.) lignocaine 1mg/kg with placebo27 failed to Simple analgesics and traditional NSAIDs demonstrate a difference in relief of migraine headache. In comparative studies lignocainehas been less effective than chlorpromazineand dihydroergotamine.28 Anti migraine drugs are considerably more expensive: Acute MigraineTreatment
• Treat attacks promptly with effective agents that terminate the attack as early as possible.
• Although stronger medications tend to be necessary for treating severe migraine attacks, many attacks can be controlled with simple analgesics, especially if taken promptly.
• Arrange follow up visit for evaluation of response to therapy and further education.
Stage of migraine
Recommendation
Other options
evidence
evidence
Early / mild migraine
Aspirin 600-900mg initially followed by 600 mg every 4 hours Paracetamol 1000mg every 4 hours (max 4g paracetamol/day) Metoclopramide 10 mg orally orProchlorperazine 5 mg orally Avoid NSAIDs, including COX-2 inhibitors, in Metoclopramide will improve gastric emptying which may patients who are volume depleted, elderly or have renal dysfunction. Avoid conventional NSAIDs in patients with a history of peptic ulcer disease.
Prochlorperazine will cause greater sedation (which may be desirable for some patients) Domperidone 20 mg may be useful for patients Level 2with a history of dystonic reactions tophenothiazines or metoclopramide Persistent / moderate
Aspirin 900 mg followed by aspirin 600 mg every 4 hours to severe migraine
Ergotamine 1-2 mg orally as an initial dose (if there is no response to 100 mg a second dose will Metoclopramide 10 mg orally or prochlorperazine 5 mg orally Persistent / Moderate
to severe migraine
Metoclopramide 10 mg IM or IV or prochlorperazine 12.5mg IM Sumatriptan 6 mg SC. A second dose may be given after one hour but only if there is a response to the first dose Prochlorperazine suppositories may be useful Metoclopramide 10 mg IM or IV or prochlorperazine 12.5mg IM OR, if in a monitored environment,
Chlorpromazine 12.5-25mg IV or IM* (Note sedative and hypotensive effects. IM injection can cause sterile abscesses.)*see general discussion Severe migraine and
patient has taken
ergotamine or triptan
(Note sedative and hypotensive effects. IM injection can cause without effect
Chlorpromazine has been shown in small RCTs to be at least as If ergotamine trial ineffective, wait 6 hours and effective as dihydroergotamine, sumatriptan (unblinded study), try sumatriptan. If triptan trial ineffective, wait ketorolac and pethidine plus promethazine Migraine during
Paracetamol 1000mg orally or rectally every 4 hours pregnancy
OR, if in a monitored environment,
*see general discussion, pages 4-5 Follow up visits
Education
• Reassure the patient• Discuss self management of acute migraine episodes with emphasis on early treatment and avoiding precipitating factors • Encourage patient to return for regular review if episodes of migraine occur frequently• In cases of repeated migraine episodes discuss prophylaxis• Discuss overlapping pain syndromes such as tension-type headache and associated nuchal myalgia and medication induced headache Assessment of the
• Ascertain the effectiveness of the treatment regimen used in the last migraine episode efficacy of treatment
• Discuss progression of migraine, timing of therapy and adverse effects used in previous
• If the previously used regimen did not produce acceptable results the alternative migraine episode
options for management of migraine episode should be tried in a stepwise fashion Plan for self
• Discuss/agree on treatment goals for the drug management of acute episodes medication
• Agree on how treatment success will be measured in subsequent
• Select a treatment option based on the patient’s treatment experience and migraine
features of the migraine episode. The options for self-management are identical to those outlines in the table within the limits of the patient’s ability to self-administer the medication.
Levels of evidence
Evidence obtained from systematic review of relevant randomised controlled trials Evidence obtained from one or more well-designed, randomised controlled trials Evidence obtained from well-designed, non-randomised controlled trials; or from welldesigned cohort or case control studies Opinions of respected authorities based on clinical experience, descriptive studies,reports of expert committees WHY PETHIDINE IS NOT RECOMMENDED 2
• Pethidine has a shorter duration of action than morphine with no additional analgesic benefit • It has similar side-effects to morphine, including increased biliary pressure • Pethidine is metabolised to norpethidine, which has potential toxic effects (eg convulsions), especially in patients with renal dysfunction, • Pethidine is associated with potentially serious interactions in combination with other drugs.
Because of its euphoric effects:
• Pethidine is the drug most commonly requested by patients seeking opioids, and • Pethidine is the drug most commonly abused by health professionals.
References
1. Silberstein SD, Rosenberg J. Multispecialty consensus on diagnosis 13. Boureau F, Joubert JM, Lassere V, Prum B, Delecoeuillerie G. 23. Bombardier MD, Laine L, Reicin A, et al (for the VIGOR study group).
and treatment of headache. Neurology 2000; 54:1553-.
Double-blind comparison of an acetaminophen 400mg-codeine 25mg Comparison of upper gastrointestinal toxicity of rofecoxib and combination versus aspirin 1000mg and placebo in acute migraine naproxen in patients with rheumatoid arthritis. NEJM 2000; 343: 2. Bramley-Moore SR, Wodak AD, Day RO, Lauchlan RL. Patterns attack. Cephalagia 1994; 14:156-161.
and methods of regulation of analgesic prescribing for patients withchronic non-malignant pain in NSW. Aust J Hosp Pharm 1998; 28.
14. De Craen AJM, Di Giulio G, Lamp-Schoenmaeckers A, Kessels AGH, 24. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity LKleijnen J. Analgesic efficacy and safety of paracetamol-codeine with celecoxib vs nonsteroidal anti-inflammatory drugs for 3. Bell J. Australian trends in opioid prescribing for chronic non-cancer combinations versus paracetamol alone: a systematic review. Br Med J osteoarthritis and rheumatoid arthritis. The CLASS study: pain 1986-1996. MJA 1997; 167:26-29.
a randomised controlled trial. JAMA 2000; 284:1247-1255.
4. National Health and Medical Research Council. Acute pain 15. Hakkarainen H, Quiding H, Stockman O. Mild analgesics as an 25. Pittler MH, Vogler BK, Ernst E. Feverfew for preventing migraine. management: scientific evidence. Canberra: Commonwealth of alternative to ergotamine in migraine. A comparative trial with In: The Cochrane Library 2002; Issue 1:Oxford:Update Software.
acetylsalicylic acid, ergotamine tartrate, and a dextropropoxyphene 26. Diamond S. A fresh look at migraine therapy. New treatments promise 5. Silberstein SD. Practice parameter: Evidence-based guidelines for compound. Journal of Clinical Pharmacology 1980; 20:590-595.
improved management. Postgraduate Medicine 2001; 109:49-60.
migraine headache (an evidence-based review): Report of the Quality 16. Australian Drug Reactions Advisory Committee. Tramadol and Standards Subcommittee of the American Academy of Neurology.
27. Reutens DC, Fatovich DM, Stewart-Wynne EG, Prentice DA. serotonin syndrome. ADRAC Bulletin 2001; 21:14.
Is intravenous lidocaine clinically effective in acute migraine? 17. Oldman AD, Smith LA, McQuay HJ, Moore RA. Pharmacological 6. Bartleson JD. Treatment of migraine headaches (review). Mayo Clinic treatments for acute migraine: quantitative systematic review. 28. Bell R, Montoya D, Shuaib A, Lee MA. A comparative trial of three agents in the treatment of acute migraine headache. Ann Emerg Med 7. Erlington G. Migraine: diagnosis and management. Journal of 18. Goadsby PJ, Lipton RB, Ferrari MD. Migraine-current understanding Neurology, Neurosurgery and Psychiatry 2002; 72:ii10-ii15.
and treatment. N Engl J Med 2002; 346:257-70.
29. Silberstein SD, Welch KMA. Painkiller headache. Neurology 2002; 8. Matchar DB, Young WB, Rosenberg JA, et al. Evidence-based 19. Tfelt-Hansen P, Henry P, Mulder LJ, Scheldewaert RG, Schoenen J, guidelines for migraine headache in the primary care setting: Chazot G. The effectiveness of combined oral lysine acetylsalicylate pharmacological management of acute attacks. Available from 30. Jones J, Pack S, Cun E. Intramuscular prochlorperazine versus and metoclopramide compared with oral sumatriptan for migraine.
the American Academy of Neurology (online). Available at: metoclopramide as single-agent therapy for the treatment of acute http://www.ann.com. Accessed October 15 2002.
migraine headache. Am J Emerg Med 1996; 14:262-264.
20. Anonymous. Acute treatment of migraine attacks: efficacy and 9. Therapeutic Guidelines: Neurology. Version 2. Melbourne: Therapeutic 31. Coppola M, Tealy DM, Leibold RA. Randomised placebo controlled safety of a nonteroidal anti-inflammatory drug, diclofenac-potassium, evaluation of prochlorperazine versus metoclopramide for emergency in comparison to sumatriptan and placebo. The Diclofenac- department treatment of migraine headache. An Emerg Med 1995; 10. Silberstein S. Preventative treatment of migraine: an overview.
K/Sumatriptan Migraine Study. Cephalagia 1999; 19:232-240.
21. Shretha M, Sing R, Moreden J, Hayes JE. Ketorolac vs chlorpromazine 32. Ryan R, Elkind A, Baker CC, et al. Sumatriptan nasal spray for the 11. Noble SL, Moor KL. Drug treatment of migraine: an overview. Am Fam in the treatment of acute migraine without aura. acute treatment of migraine. Results of two clinical studies. A prospective, randomised, double-blind trial. Arch Intern Med 1996; 12. Ramadan NM, Silbersteine SD, Freitag FG, Gilbert TT, Frishberg BM.
33. Tfelt-Hansen P. Efficacy and adverse events of subcutaneous, oral, and Evidence-based guidelines for migraine headache in the primary care 22. Davis CP, Torre PR, Williams C, Gray C, Barrett, et al. Ketorolac vs intranasal sumatriptan used for migraine treatment: a systematic review setting: phamacological management for prevention of migraine: meperidine-plus-promethazine treatment of migraine headache: based on numbers needed to treat. Cephalagia 1998; 18:532-528.
The US Headache Consortium. Neurology (serial online). Available evaluations by patients. Am J Emerg Med 1995; 13:146-150.
at: http://www.neurology.org. Accessed October 15 2002.
These guidelines were developed by
A Steering Committee was established to advise on the development of these guidelines
the NSW Therapeutic Assessment
and the field review process. Committee membership included:
Group Inc (NSW TAG). NSW TAG is an
Dr Betty Chan, Emergency Physician, Prince of Wales Hospital association of clinical pharmacologists,
A/Professor Milton Cohen, Rheumatologist and Pain Physician, St. Vincent’s campus, Sydney directors of pharmacy and other
Ms Gabrielle Couch, Manager, Pharmacy Services, Southern Area Health Service clinicians from the teaching hospitals
Professor Richard Day, Director, Clinical Pharmacology an Toxicology, St Vincent’s Hospital in New South Wales. NSW TAG aims to
Ms Kanan Gandecha, Principal Pharmaceutical Adviser, Pharmaceutical Services Branch, NSW Health investigate and establish therapeutic
Dr Tony Gill, Clinical Director, Drug Programs Bureau, NSW Health initiatives that foster high quality,
Dr Andis Graudins, Emergency Medicine Department, Westmead Hospital cost-effective drug usage in the
Dr Anna Holdgate, Deputy Director, Emergency Medicine, St George Hospital public hospitals of NSW and the
Ms Karen Kaye, Executive Officer, NSW Therapeutic Assessment Group wider community.
Ms Margaret Knight, Consumer representative Mr Andrew Leaver, Physiotherapist, Vice President, Australian Physiotherapy Association (NSW) For further information contact:
Ms Judith Mackson, Education and QA Program Manager, National Prescribing Service NSW TAG, P O Box 766, Darlinghurst NSW 2010, A/Professsor Andrea Mant, Area Adviser, Quality Use of Medicines Services, South East Health Phone: (02) 8382 2852 / Fax: (02) 9360 1005 Dr Alan Molloy, Director, Cancer and Chronic Pain Clinic, Royal North Shore Hospital Ms Wendy Rotem, Project Officer, NSW TAG Professor Paul Seale (Committee Chairman), Professor of Clinical Pharmacology, University of Sydney A/Professor Paul Spira, Neurologist, Bondi Junction Dr Simon Willcock, General Practice Unit, University of Sydney, Royal Australian College of General Practitioners Dr Alex Wodak, Alcohol and Drug Service, St Vincent’s Hospital THERAPEUTIC
Professor Nicholas Zwar, Director, Professor of General Practice, University of New South Wales ASSESSMENT
NSW TAG acknowledges with thanks the assistance of individuals and organisations who providedcomments and constructive suggestions during the field review process.
Funded by

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