British Journal of Oral and Maxillofacial Surgery (2000) 38, 593595

2000 The British Association of Oral and Maxillofacial Surgeons

doi: 10.1054/bjom.2000.0534

BRITISH JOURNAL OF ORAL

& M A X I L L O FAC I A L S U R G E RY

Intranasal midazolam as an alternative to general anaesthesia in the

management of children with oral and maxillofacial trauma
C. J. Lloyd,* T. Alredy, J. C. Lowry
*Specialist Registrar, North Wales Oral and Maxillofacial Surgery Training Programme, Glan Clwyd District
General Hospital, Rhyl, North Wales; Senior House Officer, Department of Oral and Maxillofacial Surgery,
Blackburn Royal Infirmary, Blackburn; Consultant, Department of Oral and Maxillofacial Surgery, Royal
Bolton Hospital, Bolton, UK
SUMMARY. The study assessed the dosage, clinical sedative effect, and safety of intranasal midazolam in 32
children. Data were complete for 29 patients (21 with lacerations and 8 cases of dental trauma). Sedation was
adequate to ensure successful completion of treatment under local with or without topical anaesthetic in 22 of
the 29 cases (76%). They became sedated at a mean (SD) of 14 (5) minutes, with completion of treatment at 20
(13) minutes. Sedation was achieved with a mean (SD) of 5 (2) mg of midazolam. There were no signs of
respiratory depression or of oxygen desaturation below 94% on pulse oximetry. No supplemental oxygen was
required and there were no other complications. We conclude that intranasal midazolam is a safe and effective
alternative to general anaesthesia in the definitive treatment of children with oral and maxillofacial injuries.
2000 The British Association of Oral and Maxillofacial Surgeons

INTRODUCTION

PATIENTS AND METHODS

Oral and maxillofacial trauma is common in children:

the Blackburn unit alone has about 150 cases a year,
referred for definitive management under general anaesthesia. They are a considerable burden on our clinical
and financial resources, and a general anaesthetic and
hospital admission increase morbidity and distress.
Local anaesthetics used alone provide analgesia for
definitive surgical treatment but have little effect on the
patients fear and anxiety. Physical restraint, when cooperation is inadequate, raises anxiety in both patient and
parent, and may result in suboptimal or incomplete treatment. Sedation and local anaesthesia combined seem to
produce a suitable alternative to general anaesthesia or
local anaesthesia alone.1,2
Midazolam (Hypnovel; Roche Products Limited,
Hertfordshire, UK) is a fast-acting, water-soluble benzodiazepine with sedative, anxiolytic, and amnesic properties, and a short elimination half-life. It is conventionally
given parenterally but this can be technically difficult
and a major source of anxiety, discomfort, and trauma in
children. The oral and rectal routes for delivery of midazolam have been associated with variable and often
delayed sedation and recovery.3,4 However, intranasal
midazolam has been shown to be an effective preoperative sedative: a dose of 0.20.6 mg/kg produces sedation
within 1020 minutes without serious side-effects.57 It
has also been used in paediatric dentistry8 and for the
therapeutic management of childhood seizures.9
Clinical data on the use of intranasal midazolam in
the management of trauma are limited10,11 and there is
none specifically concerned with oral and maxillofacial
trauma.

We recruited 32 children with either a facial laceration

or oral or dental trauma, in order to study the dosage
required, clinical sedative effect, and safety of midazolam delivered intranasally. Patients were eligible for
inclusion in the study only if we thought treatment with
local anaesthesia alone or with topical anaesthesia was
not possible because of the extent of injury or their lack
of cooperation or both. Children would otherwise have
received a general anaesthetic for definitive treatment of
their injuries. We obtained the approval of the Local
Ethics Committee and the informed consent in writing
of the parents.
We treated all patients in the Accident and Emergency
Department or the treatment room of the paediatric ward,
and used continuous pulse oximetry; airway management equipment was available. A surgeon, a nurse experienced in paediatric sedative techniques, and a parent
were present throughout the procedure. Intravenous
access was not required.
We delivered midazolam in a standard 5 mg/ml solution with a 1 ml needleless syringe into alternate nostrils
over a period of 30 seconds to provide an initial dose
of 0.2 mg/kg. We repeated the dose to a maximum of
0.5 mg/kg if there was no clinical sedative response after
1015 minutes. Definitive treatment was done once
the child was sedated, with additional topical or local
anaesthesia.
We collected personal and clinical data that included
age, sex and weight, and the pattern of the injury.
We recorded the dose of midazolam given (mg/kg), time
to onset of sedation, duration of treatment, time to
discharge, and the lowest recorded oxygen saturation.
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British Journal of Oral and Maxillofacial Surgery

We deemed children described as cooperative, sleepy, or

with good to excellent sedation who did not require
physical restraint during treatment to have been adequately sedated. Children who cried, were uncooperative, or required physical restraint we considered to have
had unsatisfactory sedation.11 Data are presented as
mean (SD) where appropriate.
RESULTS
Clinical details of the 29 patients for whom we had complete documentation for analysis are shown in Table 1.
All 29 children received supplemental local anaesthesia
and five had topical anaesthesia in addition to intranasal
midazolam.
The use of intranasal midazolam allowed us to treat
successfully 22 of the 29 cases (76%). Where successful,
sedation was achieved with 0.20.5 mg/kg of midazolam
with a mean of 5 (2) mg. We obtained clinically adequate sedation at a mean of 14 (5) minutes with completion of treatment at 20 (13) minutes (Table 2). There
were no instances of respiratory depression or of oxygen
desaturation below 94% on pulse oximetry. No supplemental oxygen was required and no other complications
arose. All the patients whose treatment was successful
were discharged within four hours. We did not think that
the unsuccessful treatments were related to the age of
the patient or the site of the operation. There was no correlation between dosage and clinical efficacy.
DISCUSSION
It can be technically difficult to give drugs parenterally
to children, and the method is a major source of anxiety,
discomfort, and distress. The absorption of intramuscular midazolam is also unpredictable. Intranasal midazolam avoids these difficulties. The delivery of the drug is
technically easy although initial nasal burning and irritation is reported in between one-quarter and one-half of

all patients (in our study 11 of the 29 children, 38%).

Copious nasal secretions make the intranasal route difficult to use but there are no other relative or absolute contraindications to the technique apart from those that
apply to the use of midazolam in general.
Intranasal midazolam acts rapidly and reliably because
delivery by the nasal route avoids first pass hepatic metabolism allowing maximum serum levels to be reached at
1216 minutes12 and sedation at a mean of 14 minutes in
this study. This seems to us better than oral midazolam,
where absorption is affected by first pass hepatic metabolism, and gastric contents and emptying, which produce
peak plasma levels at 45 minutes, sedation at 2030
minutes, and a wider dosage range of 0.20.75 mg/kg.2,13
The sedation induced by midazolam given rectally is
similar to that delivered intranasally, but with the onset
of action delayed to 20 minutes.14 The efficacy of midazolam delivered sublingually cannot be assessed from the
data so far published.15
Where sedation was effective, intranasal midazolam
sedated the patient long enough for us to complete the
treatment in all cases, with rapid recovery. Patients
under 5 years of age were the easiest to manage with this
technique, and not surprisingly higher doses of midazolam of 0.40.5 mg/kg were the most efficacious. More
data on the doseresponse relationship, and the ideal
group and age for treatment are required.

CONCLUSION
Our study suggests that intranasal midazolam approaches
the ideal drug and method of delivery for the sedation of
children with oral and maxillofacial trauma who would
have otherwise have been given a general anaesthetic. It
is an efficacious, safe, cost-effective, and time-saving
combination. A dose of 0.20.5 mg/kg of midazolam produced clinically adequate sedation to complete definitive
treatment in 22 (76%) of our patients.
Acknowledgements

Table 1 Clinical details of children with oral and

maxillofacial trauma treated with intranasal midazolam
(n:29)
Sex:
Male
Female
Mean (SD) age (months)
Range
Mean (SD) weight (kg)
Range
Injury:
Facial laceration
Dental trauma

18
11
51 (28)
19115
19 (8)
1145
21
8

Table 2 Pharmacodynamics of intranasal midazolam

in children with oral and maxillofacial trauma who
were successfully sedated (n:22)
Mean (SD)
Onset of sedation (min)
Completion of treatment (min)
Dosage (mg)

14 (5)
20 (13)
5 (2)

We thank Mr A. E. Green, Mr S. G. Langton, and Miss M. E. Morton,

for permission to include patients under their care, and Mr P. D. Earl
and Mr M. J. Edmondson, for help with the study. We also thank the
staff in the accident and emergency and paediatric surgical wards.

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The Authors
C. J. Lloyd MSc, FDSRCS, FRCS
Specialist Registrar
North Wales Oral and Maxillofacial Surgery Training Programme
Glan Clwyd District General Hospital
Rhyl
North Wales, UK
T. Alredy BDS
Senior House Officer
Department of Oral and Maxillofacial Surgery
Blackburn Royal Infirmary
Blackburn, UK
J. C. Lowry FDSRCS, FRCS, MHSM
Consultant
Department of Oral and Maxillofacial Surgery
Royal Bolton Hospital
Bolton, UK
Correspondence and requests for offprints to: C. J. Lloyd MSc,
FDSRCS, FRCS, Specialist Registrar, Department of Oral and
Maxillofacial Surgery, Glan Clwyd District General Hospital,
Rhyl, North Wales LL18 5UJ, UK. Tel: ;44 (0)1745 583910;
Fax: ;44 (0)1745 583143
Paper received 25 August 1999
Accepted 24 July 2000

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