Buccal midazolam is usually preferred to rectal diazepam in the hospital setting and for patients with a personalised seizure management plan. However, there are a number of practical challenges for ambulance services which mean that buccal midazolam may not be a feasible alternative in the pre-hospital setting, at least in the medium term. Therefore many UK ambulances stock rectal diazepam in the available 5mg and 10mg presentations.
This guidance is produced by the Neonatal and Paediatric Pharmacy GroupÌý(NPPG) and is endorsed by the RCPCH-NPPG Joint Standing Committee on Medicines.
Summary guidance
- Rectal diazepam is stocked on many UK ambulances for pre-hospital management of prolonged seizures.
- At the present time, the 2.5mg diazepam rectal tubes are no longer available. The 5mg and 10mg presentations remain available.
- Current guidelines published by Joint Royal Colleges Ambulance Liaison Committee (JRCALC) advise that rectal diazepam doses of 1.25mg or 2.5mg be administered to neonates and infants having a prolonged seizure.Ìý
- It is not possible to accurately administer a 1.25mg or 2.5mg dose directly from a 5mg rectal tube. As a result we advise that the required dose is decanted as below (note: the equipment recommended is that designed for enteral administration, ie ENFit, to reduce the risk of inadvertent IV administration).
To administer a 1.25mg dose
- Attach an ENFit blunt fill needle to a 1mL ENFit syringe
- Withdraw 0.63mL (1.25mg) of liquid from a 5mg diazepam rectal tube
- Discard the ENFit blunt fill needle
- Attach a flexible ENFit medicine straw to the syringe
- Pull back on the syringe plunger to draw in approximately 0.5mL of air
- After positioning the patient, carefully insert the medicine straw as far as is comfortable into the rectum
- Administer the liquid contained within the syringe, keeping the air bubble at the plunger end of the syringe so that the bubble flushes the full dose through the medicine straw
- Keep the syringe plunger depressed whilst removing the medicine straw from the patient’s rectum
To administer a 2.5mg dose
- Attach an ENFit Blunt Fill Needle to a 2mL or 3mL ENFit syringe
- Withdraw 1.25mL (2.5mg) of liquid from a 5mg diazepam rectal tube.
- Discard the ENFit blunt fill needle
- Attach a flexible ENFit medicine straw to the syringe
- Pull back on the syringe plunger to draw in approximately 0.5mL of air
- After positioning the patient, carefully insert the medicine straw as far as is comfortable into the rectum
- Administer the liquid contained within the syringe, keeping the air bubble at the plunger end of the syringe so that the bubble flushes the full dose through the medicine straw
- Keep the syringe plunger depressed whilst removing the medicine straw from the patient’s rectum
Supporting information
Benzodiazepines, including rectal diazepam, are routinely used in the management of prolonged seizures. Diazepam is available as rectal tubes, designed to allow easy administration via this route. Rectal tubes containing 2.5mg, 5mg or 10mg have historically been available in the UK. However, in late 2021 the 2.5mg dose was discontinued by the sole manufacturer; the 5mg and 10mg presentations remain available.1
A number of seizure management guidelines, including those published by the , recommend administration of either 1.25mg or 2.5mg doses of rectal diazepam to neonates and infants.2 Ambulance Service staff in the UK, including Paramedics, follow JRCALC guidance when treating prolonged seizures in the pre-hospital setting, administering diazepam under a Patient Group Direction or Group Authority.3 Ìý
It is not possible to accurately administer a 1.25mg or 2.5mg dose directly from either a 5mg or 10mg rectal tube. As a result, it is necessary to decant the required dose before administration, although this is not without risk. In developing the guidance presented in Summary guidance, above, it is assumed that 1.25mg or 2.5mg doses will be given from 5mg rectal tubes, which contain 5mg in 2.5mL (2mg/mL). If it becomes necessary in practice to administer the 1.25mg or 2.5mg doses from a 10mg rectal tube, it must be noted that the concentration of the drug solution is different, ie10mg in 2.5mL (4mg/mL).
To reduce risk of administration of diazepam rectal solution via the intravenous route, we recommended that the syringes and associated equipment used are those designed for enteral administration (ENFit). Inadvertent administration via the intravenous route of a medicine intended for enteral administration (which includes the rectal route) is defined as a Never Event by NHS England.4
Rectal diazepam is one of several treatments used for prolonged seizures in neonates and infants. Buccal midazolam is one such alternative. Studies suggest that buccal midazolam is as effective as rectal diazepam at resolving seizures, if not more effective, and that buccal midazolam is probably the preferred option for many patients.5 Ìý6 Ìý7 However, routine use of buccal midazolam by ambulance staff in the pre-hospital scenario presents a number of challenges which cannot be easily overcome in the time available to implement changes required by the discontinuation of the diazepam 2.5mg rectal tube. Buccal midazolam and rectal diazepam are both recommended treatment options in the current NICE guidance.8 JRCALC guidelines do, however, advocate administration of a patient’s own buccal midazolam where this is available as part of a personal seizure management plan.2 Although intravenous phenobarbital may be considered the treatment of choice for neonatal seizures,9 but this is not currently available nor suitable for routine administration in the prehospital setting.
Pictorial guide A - administering a 1.25mg dose
Equipment needed:
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Attach an ENFit blunt fill needle to a 1mL ENFit syringe |
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Withdraw 0.63mL of liquid from a 5mg diazepam rectal tube |
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Prior to administration, invert the syringe so that the air bubble is at the plunger end of the syringe |
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Administration:
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Pictorial guide B - administering a 2.5mg dose
Equipment needed:
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Attach an ENFit blunt fill needle to a 2.5mL or 3mL ENFit syringe |
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Withdraw 1.25mL of liquid from a 5mg diazepam rectal tube |
|
|
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Prior to administration, invert the syringe so that the air bubble is at the plunger end of the syringe |
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Administration:
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- 1DHSC & NHS England and Improvement: Diazepam RecTubes 2.5mg Rectal Solution - Supply Disruption, October 2021.
- 2 a b JRCALC Clinical Guidelines. Cited from: JRCALC Plus (2022) (Version 1.2.17) [Mobile application software]. Bridgwater: Class Publishing Ltd. Accessed 21/07/2022.
- 3Specialist Pharmacy Service, National Ambulance Service Medical Directors (NASMeD) and the Joint Royal Colleges Ambulance Liaison Committee (JRCALC): Administration of diazepam rectal tubes by registered Paramedics and Nurses for the management of seizures: PGD template, April 2020.
- 4NHS Improvement, Never Events List 2018 (last updated February 2021).
- 5McIntyre J, Robertson S et al. Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial. Lancet. 2005;366(9481):205-10.
- 6Baysun S, Aydin OF et al. A comparison of buccal midazolam and rectal diazepam for the acute treatment of seizures. Clin Pediatr (Phila). 2005;44(9):771-6.
- 7Nakken K, Lossius. Buccal midazolam or rectal diazepam for treatment of residential adult patients with serial seizures or status epilepticus. Acta Neurol Scand. 2011;124(2):99-103.
- 8National Institute for Health and Care Excellence. Epilepsies: diagnosis and management (CG137). London: NICE; 2012.
- 9World Health Organisation. Guidelines on Neonatal Seizures. WHO; 2011.