Departmental (Case) Discussion[1]

Departmental (Case) Discussion : 

Departmental (Case) Discussion Samir Dawlatly GP VTS SHO 23 December 2008

Not exactly a case… : 

Not exactly a case… Need to brush up on background knowledge …therefore decided to present a paper

Summary : 

Summary Why I chose what I did Background – review of NICE, DTB and patient information leaflet Appraisal of trial Conclusions

What to present? : 

What to present? Subscriptions to BMJ and BJGP Online access to others BMJ more applicable to more people

Paediatric Research in BMJ in last few months : 

Paediatric Research in BMJ in last few months Effects of improved heating on asthma in community dwelling children: randomised controlled trial Early head injury and ADHD: retrospective cohort study Misperceptions and misuse of Bear Brand coffee creamer as infant food: national cross sectional survey of consumers and paediatricians in Laos Patterns of skeletal fractures in child abuse: systematic review Do overweight children become overweight adults? Drug use in children: cohort study in three European countries

What I did choose and why : 

What I did choose and why Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial BMJ Vol 337(7672): 729-733 (abridged version) I have given my daughter both in the past A consultant here stated he didn’t like giving ibuprofen that much Management of febrile illness in children is an important learning outcome

Appraising a trial : 

Appraising a trial Background – what is already known? Is the trial valid? What are the results? Will the results help locally?

What NICE has to say(CG47 May 2007) : 

What NICE has to say(CG47 May 2007) Consider either paracetamol or ibuprofen as an option if the child appears distressed or is unwell. Take the views and wishes of parents and carers into account when considering the use of antipyretic agents. Do not routinely give antipyretic drugs to a child with fever with the sole aim of reducing body temperature. Do not administer paracetamol and ibuprofen at the same time, but consider using the alternative agent if the child does not respond to the first drug. Do not use antipyretic agents with the sole aim of preventing febrile convulsions

What the DTB has to sayMarch 2007 : 

What the DTB has to sayMarch 2007 Little evidence on the effects of antipyretic drug therapy on discomfort associated with fever Insufficient evidence on whether antipyretic drugs help to prevent febrile seizures. Symptoms, such as myalgia or headache are likely to benefit from treatment with paracetamol or ibuprofen. Paracetamol is the preferred option for a child with renal impairment or who is dehydrated or at risk from gastric bleeding or ulceration. There is no clear advantage from using both paracetamol and ibuprofen, either together or alternately.

What we tell patients… : 

What we tell patients…

From patient.co.uk : 

From patient.co.uk Can febrile seizures be prevented? It may seem logical that if you keep a child's temperature down during a feverish illness it may prevent a febrile seizure. However, there is little scientific evidence to prove that this is so. … However, it is common practice to keep a child cool when they have a feverish illness. This will make them feel more comfortable. Therefore, if a child appears hot, then the following will help to reduce the temperature: Keep the child very lightly dressed, or take all their clothes off if the room is warm. Give paracetamol, (for example, Calpol, Disprol, etc), or ibuprofen. Give lots of cool drinks.

Returning to the trial in question : 

Returning to the trial in question Advertised under the tag line: “Which drug for feverish children”…

Background : 

Background Paracetamol and ibuprofen are superior to placebo for relief of fever 5 previous trials in secondary care looked at single doses and gave conflicting evidence Community-based trial between Jan 2005 and May 2007 in Bristol area 156 participants

Is the trial valid? [1] : 

Is the trial valid? [1] Is there a clearly focussed question? “To investigate whether paracetamol plus ibuprofen are superior to either drug alone for increasing time without fever and the relief of fever associated discomfort in febrile children managed at home” Is it an RCT? Was this the right design? yes and yes Were participants appropriately allocated to intervention and control groups? Yes

Is the trial valid? [2] : 

Is the trial valid? [2] Were participants, staff and study personnel “blind” to the study groups? yes (except for 4 patients) Are all participants accounted for? yes Were all participants followed up in the same way yes Was the study adequately powered? No – nowhere near…

What are the results? [1] : 

What are the results? [1] What are the main results and how are they presented? How precise are the results? no p values in table or text But these appear in the abstract

Secondary outcomes at 24 hrs : 

Secondary outcomes at 24 hrs

Secondary outcomes at 48 hrs and 5 days : 

Secondary outcomes at 48 hrs and 5 days

What are the results? [2] : 

What are the results? [2] Do they make sense (biologically plausible)? yes, probably Do other studies confirm the findings? other reviews conclude that combination is similar to ibuprofen alone Were all important outcomes considered so the results can be applied? yes, probably

Will the results help locally : 

Will the results help locally Does the study population reflect our own? Primary care setting – therefore children probably not as sick as those in secondary care Children admitted to hospital excluded Important for children seen in the ED Very useful for me as a future GP Can the trial conditions truly reflect normal clinical practice? I think so yes – parents giving medication

Authors’ conclusions : 

Authors’ conclusions If you want to maximise the time that children spend without fever you should use ibuprofen first Consider the relative benefits and risks of using paracetamol plus ibuprofen over 24 hours As an aside – they found a possible relation between temperature and discomfort

What I thought of the trial… : 

What I thought of the trial… Reading abridged version was frustrating Felt dumbed down – using phrases like “strong evidence” instead of “statistically significant” Low number of children No stats on baseline data ?Selection bias – what about the baseline stats of those eligible that refused to enter Included patients with temp less than 38oC High dose of ibuprofen used (10mg/kg) TDS

More of what I thought… : 

More of what I thought… No stats on mean temperature No stats on temperature-discomfort relation No difference in discomfort at 48 hours Surely that’s why you should be giving anti-pyretics in the first place? Did the medicines taste different?

What I learnt : 

What I learnt Routine use of anti-pyretics is not indicated in fever Anti-pyretics should be used to treat symptoms of fever and not a number (temperature) High dose ibuprofen may lower fever quicker Combination therapy probably no better than ibuprofen alone, and more likely to result in over dosage It’s difficult to recruit children to a trial

Thank you : 

Thank you Any questions or comments?

Baseline data 1 : 

Baseline data 1

Baseline data 2 : 

Baseline data 2

Baseline data 3 : 

Baseline data 3