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National Collaborating Centre for Women's and Children's Health

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Spasticity in children <strong>and</strong> young people with non-progressive brain disorders<br />

use of the term ‘consider’ (rather than ‘offer’) <strong>and</strong> through specific advice about which drugs should be<br />

used, <strong>and</strong> how <strong>and</strong> when they should be introduced, monitored <strong>for</strong> effectiveness <strong>and</strong> discontinued.<br />

The GDG noted that oral benzodiazepines (especially diazepam) are frequently used in the<br />

management of spasticity in children <strong>and</strong> young people. All available trial evidence within this class<br />

was in relation to diazepam. Although the evidence of effectiveness was limited, the comparative<br />

prominence of diazepam over other benzodiazepines in the available literature reflected the group’s<br />

clinical experience in terms of both its common usage <strong>and</strong> their positive experiences of using the drug<br />

to treat spasticity that was contributing to discom<strong>for</strong>t or pain, muscle spasms <strong>and</strong> functional disability.<br />

As such the GDG believed that diazepam should be the recommended benzodiazepine of choice.<br />

Equally, although the evidence of effectiveness of oral baclofen was limited, the GDG considered that<br />

its prominence in the available literature reflected current good practice <strong>and</strong> positive clinical<br />

experience <strong>for</strong> the same clinical indications as diazepam. The group there<strong>for</strong>e considered it was also<br />

appropriate to recommend baclofen.<br />

Although the GDG considered that the clinical indications <strong>for</strong> considering diazepam <strong>and</strong> baclofen<br />

overlapped, the group noted that diazepam was likely to have a more rapid onset of action than<br />

baclofen. The group concluded, there<strong>for</strong>e, that diazepam would be particularly useful in a situation<br />

where rapid onset of action would be beneficial, such as in a severe pain crisis. However, if the goal<br />

was to achieve a sustained long-term effect from oral drug treatment then baclofen would be<br />

preferred. This was because the GDG was concerned about the possibility of adverse consequences<br />

from long-term administration of a benzodiazepine such as diazepam.<br />

The GDG consensus was that a rational approach to the use of oral drugs would be to introduce them<br />

gradually with a stepwise increase in dosage aimed at optimising therapeutic benefit while minimising<br />

the risk of adverse effects such as excessive sedation. The trial evidence relating to baclofen reported<br />

benefits associated with this approach.<br />

The GDG view was that if oral diazepam was offered as treatment, this should begin as a bed-time<br />

dose. If necessary the dose could be increased stepwise <strong>and</strong>/or a daytime dose added. This was<br />

considered a particularly safe approach as it was the equivalent of giving one of the two divided doses<br />

recommended in the SPCs. This, in turn, reflected the reduced dosages reported in the evidence<br />

considered in the guideline review.<br />

When using oral baclofen, again the group considered it advisable to begin with a low dose <strong>and</strong><br />

increase it in steps over 4 weeks. The GDG’s view was that this was the appropriate time period in<br />

which to achieve the intended therapeutic goal with minimal side-effects.<br />

If oral diazepam was chosen at the outset because of its expected rapid onset of action, the GDG’s<br />

view was that consideration should be given to changing to oral baclofen later as this may have a<br />

more satisfactory long-term outcome.<br />

The GDG concluded that if an oral drug was found to have a useful effect in an individual child or<br />

young person (that is, it achieves a desired goal <strong>and</strong> is well tolerated) it should be continued as<br />

medium-term or long-term maintenance therapy. However, longer term prescription that is<br />

unnecessary <strong>and</strong> possibly ineffective should be avoided. There<strong>for</strong>e, the GDG advised that on each<br />

occasion when a child or young person is reviewed, it should be considered whether a particular drug<br />

treatment is still necessary. Treatment reviews should take place at least once every 6 months.<br />

In the event that an oral drug leads to side effects such as drowsiness, consideration should be given<br />

either to reducing the dose or discontinuing treatment. Similarly, if diazepam or baclofen used alone<br />

have no worthwhile effect within a period of 4–6 weeks then consideration should be given to a trial of<br />

combined treatment with both diazepam <strong>and</strong> baclofen. Although no evidence was identified to support<br />

the effectiveness of such combined treatment, the GDG considered that this was a rational approach<br />

given the different mechanisms of action of the two drugs.<br />

The GDG considered that there were potential adverse effects associated with withdrawal of<br />

diazepam <strong>and</strong> baclofen after a long period of treatment. The group there<strong>for</strong>e recommended that<br />

discontinuation after several weeks' use should be accomplished through staged reductions in dose to<br />

avoid withdrawal symptoms.<br />

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