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Summary for primary care

Analgesia—Mild-to-Moderate Pain

Latest Guidance Updates

November 2021: minor update. Clarified the basis for recommending paracetamol dose reduction in people with risk factors for hepatotoxicity and paracetamol overdose, including those who weigh less than 50 kg.

Overview

This updated Guidelines summary covers prescribing information on paracetamol, aspirin, and weak opioids (codeine, dihydrocodeine, and tramadol). This summary covers information relevant to pharmacists. For a complete set of recommendations, refer to the full NICE Clinical Knowledge Summary (CKS) topic.

Reflecting on your Learnings

Reflection is important for continuous learning and development, and a critical part of the revalidation process for UK healthcare professionals. Click here to access the Guidelines Reflection Record.

Choice of Analgesic

Age Younger Than 16 Years

From age 3 months onwards.

  • Prescribe either paracetamol or ibuprofen alone.
    • If the child does not respond to the first analgesic, check their adherence and that an appropriate dose is being taken. If adherence and dose are appropriate, switch analgesic:
      • If paracetamol has been used, switch to ibuprofen alone.
      • If ibuprofen has been used, switch to paracetamol alone.
    • If the child has not responded sufficiently to appropriate doses of either drug alone, consider alternating paracetamol and ibuprofen.
      • Add a dose of the second drug (for example, 2–3 hours after the first drug), provided that the parents/carers are confident to do this.
      • Paracetamol is usually given every 6 hours and ibuprofen every 8 hours. Care needs to be taken not to exceed the maximum dose of each drug in a 24-hour period.
      • A treatment diary may be useful if the parents or carers find it difficult to remember which was the last drug given and at what time.
      • If the child is still in pain or more than short courses of analgesics are required, consider seeking specialist advice.
    • Treat the underlying cause of the pain whenever possible.
  • The following treatment options are not recommended for children in primary care:
    • Use of paracetamol and ibuprofen at the same time
    • Naproxen
    • Diclofenac
    • Aspirin
    • Weak opioids (codeine, dihydrocodeine, and tramadol).

Age 16 Years and Older

  • In adults and children aged 16 years and older, a stepwise strategy for managing mild-to-moderate pain in adults is recommended:
    • Step 1—start paracetamol.
    • Step 2—substitute the paracetamol with ibuprofen. If the person is unable to take a nonsteroidal anti-inflammatory drug (NSAID), use a weak opioid (such as codeine phosphate).
    • Step 3—add paracetamol to the ibuprofen or weak opioid.
    • Step 4—continue with paracetamol and replace the ibuprofen with an alternative NSAID (such as naproxen).
    • Step 5—add a weak opioid to the paracetamol and/or NSAID.
  • When prescribing analgesics:
    • Ensure a full therapeutic dose of one analgesic is used before switching to (or combining with) another analgesic.
    • Treat the underlying cause of the pain whenever possible.
    • Ensure that people who experience continuous pain receive regular analgesia following a full clinical assessment.
    • Avoid combination analgesics as first-line treatment.
      • Prescribing single-constituent analgesics to allow independent titration of each drug, taking into account local prescribing guidelines.
      • Consider fixed-dose combination analgesics (except those with low-doses of opioids) for people with chronic, stable pain and for people taking a lot of tablets (to reduce the number of tablets taken). 
      • Be aware that fixed-dose combination analgesics containing low doses of opioids (such as codeine 8 mg plus paracetamol 500 mg or dihydrocodeine 10 mg plus paracetamol 500 mg) are no more effective than paracetamol alone and can cause opioid adverse effects, such as constipation.

Paracetamol

Recommended Doses

  • The recommended doses of paracetamol for people aged 18 years and older are:
    • By mouth—500 mg to 1 g every 4 to 6 hours as required (maximum 4 g in 24 hours).
    • By rectum—500 mg to 1 g every 4 to 6 hours as required (maximum 4 g in 24 hours).
  • The recommended doses of paracetamol for children aged up to 17 years are shown in Table 1 below. These doses may be repeated every 4 to 6 hours if necessary (maximum of four doses in 24 hours).

Table 1: Recommended Doses of Paracetamol for Children Aged up to 17 Years

AgeDose
Oral Dose
3–5 months60 mg
6–23 months120 mg
2–3 years180 mg
4–5 years240 mg
6–7 years240–250 mg
8–9 years360–375 mg
10–11 years480–500 mg
12–15 years480–750 mg
16–17 years500–1000 mg (1g)
Rectal Dose
3–11 months60–125 mg
1–4 years125–250 mg
5–11 years250–500 mg
12–17 years500 mg
© NICE, 2021. Reproduced with permission.
  • Use clinical judgement to adjust the dose of oral paracetamol in people with risk factors for hepatotoxicity, such as liver disease or body weight less than 50 kg. If risk factors are present:
    • Consider reducing the dose of paracetamol to a maxiumum of 3 g in 24 hours (for example 1 g three times daily) or use 15mg/kg every 4–6 hours (maximum of 60 mg/kg in 24 hours) as a guide.
    • Monitor liver function tests if increased.
    • Advise the person that they have been prescribed a lower dose and explain the reason why.
      • Advise caution when using over-the-counter paracetamol-containing products; the recommended maximum total daily dosage must not be exceeded.
      • Explain that the lower dose of paracetamol may not be stated in the manufacturer's patient information leaflet.
For recommendations on adverse effects and drug interactions of paracetamol, refer to the full CKS topic.

Pregnancy and Breastfeeding

  • Pregnancy
    • Paracetamol is the analgesic of choice for women who are trying to conceive or who are pregnant.
    • It can be used at the standard dose at any stage of pregnancy.
  • Breastfeeding
    • Paracetamol is the analgesic of choice for women who are breastfeeding.
    • Very small amounts of paracetamol pass into the breast milk, and these amounts are far below the doses that would normally be given to infants directly.
    • Seek specialist advice if:
      • The infant is pre-term or low birth weight.
      • The absorption, distribution, metabolism, or excretion of paracetamol may be affected by an underlying medical condition in the infant.
      • The mother is taking multiple medicines.

Information and Advice

  • Advise the person and/or their parents/carers that:
    • If they have continuous pain, they should use paracetamol regularly (four times a day).
    • Paracetamol rarely causes adverse effects when used at the correct dosage.
    • There are other paracetamol-containing medicines available over the counter (OTC). The recommended maximum total daily dosage must not be exceeded.
For more information and advice, refer to the full CKS topic.

Aspirin

For recommendations on contraindications and cautions of aspirin, refer to the full CKS topic.

Recommended Doses

  • The recommended analgesic dose of oral aspirin for mild-to-moderate pain in adults and children older than 16 years of age is:
    • 300–900 mg every 4 to 6 hours as required (maximum 4 g in 24 hours).
  • The recommended oral dose of aspirin for acute migraine is 900 mg for one dose, to be taken as soon as migraine symptoms develop. See the CKS topic on Migraine for more information.

For recommendations on adverse effects and drug interactions of aspirin, refer to the full CKS topic.

Pregnancy and Breastfeeding

  • Pregnancy
    • Paracetamol is the analgesic of choice during pregnancy.
    • If aspirin is being considered, be aware that analgesic doses of aspirin:
      • Are not known to be harmful when used during the first and second trimesters of pregnancy.
      • Should be avoided during the third trimester of pregnancy because:
        • There is an increased risk of haemorrhage due to impaired platelet function.
        • There may be delayed onset and increased duration of labour, with increased blood loss.
        • High doses (4 g or more) may be related to intrauterine growth restriction, teratogenic effects, closure of fetal ductus arteriosus in utero, and possibly persistent pulmonary hypertension of the newborn, and kernicterus may develop in babies who are jaundiced.
  • Breastfeeding
    • Paracetamol is the analgesic of choice during breastfeeding.
    • Do not prescribe analgesic doses of aspirin to women who are breastfeeding due to a possible risk of Reye's syndrome (a very rare but often fatal disease characterized by encephalopathy and fatty degeneration of the liver) in the baby.

Information and Advice

  • Advise the person to:
    • Take aspirin with or after food (to reduce the risk of GI adverse effects).
    • Stop aspirin and seek medical advice if they experience bronchospasm or dyspepsia.
    • Seek advice from a healthcare professional (such as a pharmacist) before buying over-the-counter (OTC) medicines. These might contain ingredients (for example ibuprofen) which can increase the risk of adverse effects from aspirin.

NSAIDs

  • See the CKS topic on NSAIDs - prescribing issues for detailed information on prescribing non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen.

Weak Opioids

Choice

  • In adults:
    • Prescribe codeine, dihydrocodeine, or tramadol if the person has an inadequate response to paracetamol and/or a nonsteroidal anti-inflammatory drug (such as ibuprofen or naproxen).
      • Tramadol is a Schedule 3 controlled drug and as such is subject to the legal prescription requirements associated with controlled drugs.
      • Codeine has to be converted to morphine in the body to achieve an analgesic effect (240 mg of codeine is approximately equivalent to 30 mg of morphine). The capacity to metabolize codeine can vary considerably between people: poor metabolizers may not experience analgesia, and ultrarapid metabolizers may experience toxicity. Use an alternative analgesic in these groups of people.
  • In children:
    • Seek specialist advice if a weak opioid is being considered to treat mild-to-moderate pain.
For recommendations on contraindications and cautions, adverse effects, and drug interactions of weak opioids, refer to the full CKS topic.

Recommended Doses

  • The recommended doses of weak opioids for mild-to-moderate pain in adults are:
    • Codeine — 30 to 60 mg every 4 hours when necessary (maximum 240 mg in 24 hours).
    • Dihydrocodeine — 30 mg every 4 to 6 hours when necessary (maximum 180 mg in 24 hours).
    • Tramadol — 50 to 100 mg every 4 to 6 hours when necessary (usual maximum 400 mg in 24 hours).
  • Lower doses of weak opioids (for example codeine 15 mg) are recommended for:
    • Elderly and/or debilitated people.
    • People with hypothyroidism and adrenocorticoid insufficiency.
    • People with moderate-to-severe chronic kidney disease (CKD).

Pregnancy and Breastfeeding

Pregnancy
  • Paracetamol is the analgesic of choice during pregnancy.
  • If a weak opioid is required, codeine is preferred.
    • Codeine can be used short term in all trimesters of pregnancy. However, the use of codeine near the end of the third trimester may cause neonatal respiratory depression. Long-term use may cause withdrawal symptoms in the baby.
Breastfeeding
  • Paracetamol is the analgesic of choice during breastfeeding. 
  • If a weak opioid is required, tramadol or dihydrocodeine may be used at the lowest effective dose and for the shortest possible duration. 
  • Regular use of any opioid in a breastfeeding mother beyond 3 days should be under close medical supervision.
  • Be aware that:
    • If significant opioid adverse effects develop in the mother, this could suggest the possibility that she is an ultrarapid metabolizer and that the risk of adverse effects in the infant may be increased.
    • Advise breastfeeding mothers who are taking weak opioids to stop breastfeeding and seek medical advice if they develop opioid adverse effects.
  • Seek expert advice if:
    • The infant is pre-term or low birth weight.
    • The absorption, distribution, metabolism, or excretion of the weak opioid may be affected by an underlying medical condition in the infant.
    • The mother is taking multiple medicines.

Information and Advice

  • Advise the person:
    • That constipation is a common adverse effect of all weak opioids.
      • A regular laxative is not usually needed for short-term use of weak opioids.
    • About driving while taking weak opioids:
      • They should not drive if they are drowsy, dizzy, unable to concentrate or make decisions, or if they experience blurred or double vision.
      • It is now an offence to drive if they have more than a specified amount of opioid in their body whether driving is impaired or not. It may be helpful for the person to keep evidence (such as their repeat prescription) in the car to show that they are taking an opioid in accordance with medical advice.
    • That overuse or misuse of opioid analgesics may result in overdose and/or death. Advise the person:
      • To only use medicines that are prescribed for them at the dose they have been prescribed and to not give this medicine to anyone else.
      • That weak opioids purchased over-the-counter (OTC) should only be used for up to 3 days before seeking medical advice.

References


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