Title: As required versus fixed schedule analgesic administration schedules for postoperative pain in children
Funder: Department of Health (England)

Abstract: 1.Intervention: Round the clock analgesia at recommended dose and interval.2.Patient group: Children with post-operative pain (surgery to be defined).3.Setting: Outpatient.4.Control: Medication as needed (PRN).5.Study design: Systematic review. 6.Important outcomes: Pain (visual analogue score) adverse effects.Other outcomes: 7.Minimum duration of follow-up: NHS decision problem to be addressed by this research: Current outpatient management of postoperative pain (e.g. following tonsillectomy) in children includes the use of oral opioid and non-opioid analgesics largely prescribed on an as needed pain contingent basis. However postoperative pain following tonsillectomy has predictable characteristics (e.g. prolonged duration relatively constant in nature moderate to severe intensity) which suggests that scheduled dosing regimens may be efficacious. Guidelines on postoperative management of paediatric pain recommend time-contingent analgesic dosing to reduce or prevent pain before it begins. Potential benefits of this approach include the maintenance of therapeutic levels of opioids the facilitation of routine postoperative activities (e.g. oral intake activity sleep) and the avoidance of delays in analgesic administration because of inaccurate parental assessment of childrens pain behaviours. However many clinicians and parents fear that regularly scheduled administration of analgesics may result in the administration of unnecessary and/or excessive amounts of analgesics which may cause undesirable and potentially harmful adverse effects. As a result children are often not given enough pain control in the post-operative period. It is therefore necessary to evaluate the current evidence to determine the benefits and/or harms of regular dosing of analgesics versus ‘when needed’ following surgery in children. Source of topic Identified by Dr Alison Twycross following RCN RiCH meeting in Sept 2013.Patient group•Children discharged home following surgery.•Thousands of children per year have operations conducted for any number of conditions and reasons. Many of these will require some form of pain relief once they are discharged from hospital and the responsibility for providing analgesia especially in younger children will fall to the parents.•In 2012-13 there were over 131000 outpatient attendances for paediatric surgery (children aged 0-16 years) (Health and Social Care Information Centre Hospital Episode Statistics for England. Outpatient statistics 2012-13).•Tonsillectomy is known to be particularly painful postoperatively. While the number of tonsillectomies conducted has fallen in recent years in 2008-09 there were 27000 tonsillectomies in those aged 15 or under (Indications for Tonsillectomy: Position Paper ENT UK 2009).NICE and other guidanceAssociation of Paediatric Anaesthetists of Great Britain and Ireland Guideline on Good Practice in Postoperative and Procedural Pain Management notes that [1]:•Postoperative analgesia should be planned and organised prior to surgery in consultation with patients and their families or carers and other members of the perioperative team.•Prior to discharge from the hospital patients and their families should be given clearly presented information and advice regarding the assessment of pain and the administration of analgesia at home.•Pain after surgery is usually most severe in the first 24–72 h but may persist for several days or weeks. •Analgesia can be given regularly (by the clock) in the early postoperative period and then ‘as required’ according to assessed pain. •Drugs to counteract unwanted effects of analgesia or other side effects of surgery such as PONV (postoperative nausea and vomiting) should also be available and administered when necessary.•Analgesic regimens should be sufficiently flexible to allow for inter-individual differences in the response to analgesics and the variation in the requirement for pain relief that occurs during the postoperative period.For tonsillectomy specifically a ‘Good practice point’ states:•As significant levels of pain behavioral disturbance sleep disruption and altered activity can persist for 5–8 days following tonsillectomy regular administration of analgesia may be necessary during this period. Information for families about pain assessment and medication use following discharge is particularly important.•A combination of individually titrated intraoperative opioids dexamethasone and regularly administered perioperative mild analgesics (NSAIDS and/or paracetamol) is recommended for management of tonsillectomy pain.Great Ormond Street – pain management after day surgery (gosh.nhs.uk) states:•Painkillers should be given regularly especially if the pain is bad. •Different types of painkiller work well together for instance paracetamol and ibuprofen can be given at the same time for the strongest effect. •Do not wait for the pain to get very bad before you give your child painkillers. •Giving painkillers at bedtime will help your child to sleep through the night.•When the pain is bad you should give the painkillers regularly ‘by the clock’. You may need to do this for several days. After that you should give painkillers when your child complains of pain.Current practice:Recommended advice to parents is as stated above however there is evidence that these guidelines are not always followed.Proposed intervention:It is proposed to conduct research to determine if giving painkillers to children following an operation ‘by the clock’ is more effective at reducing pain than ‘as needed’ (pro re nata PRN) as there are concerns among parents that regularly scheduled administration of analgesics may result in the administration of unnecessary and/or excessive amounts of analgesics which may cause undesirable and potentially harmful adverse effects. As such many parents are reluctant to treat their childrenwith pain medication or to give adequate doses of medication to control pain even when they recognize and believe that they have significant pain [2].Cost and implications for NHS spend For completion at Vignette stage.Summary of completed researchEvidence Synthesis:Chiaretti (2013) Current practice and recent advances in pediatric pain management. Searched to Jan 2012. The non-opioid analgesics (acetylsalicylic acid acetaminophen and the nonsteroidal anti-inflammatory drugs NSAIDs) constitute a heterogeneous group of compounds that differ in chemical structure but share many pharmacological actions. These drugs are useful alone for mild to moderate pain (step 1 of the analgesic ladder) and provide additive analgesia when combined with opioid drugs in the treatment of more severe pain. The administration of paracetamol in children and infants is a well-established and safe treatment option if appropriately used.“Around the clock” dosing. Patients with severe pain generally benefit from scheduled “around the clock” dosing which can provide the patient with continuous relief by preventing the pain from recurring. Most patients who receive an “around the clock” opioid regimen should also be provided a so-called “rescue dose” which is a supplemental dose offered on an “as needed” basis to treat pain that breaks through the regular schedule. The frequency with which the rescue dose can be offered depends on the route of administration and the time to peak effect for the particular drug. Oral rescue doses are usually offered up to every 1-2 hours and parenteral doses can be offered as frequently as every 15-30 minutes. The integration of “around the clock” dosing with “rescue doses” provides a method for safe and rational stepwise dose escalation which is applicable to all routes of opioid administration. Patients who require more than 4-6 rescue doses per day should generally undergo escalation of the baseline dose. The quantity of the rescue medication consumed can be used to guide the dose increment.“As needed” dosing. In some situations opioid administration on an “as needed” basis without an “around the clock” dosing regimen may be beneficial. In the opioid-naive patient “as needed” dosing may provide additional safety during the initiation of opioid therapy particularly when rapid dose escalation is needed or therapy with a long half-life opioid such as methadone or levorphanol is begun. “As needed” dosing may also be appropriate for patients who have rapidly decreasing analgesic requirement or intermittent pain separated by pain-free intervals [3].


Research activity codes: 6.1 PHARMACEUTICALS
Health categories: GENERIC HEALTH RELEVANCE