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A COMPARATIVE STUDY OF THE EFFECTIVENESS OF ORAL MIDAZOLAM AND ORAL KETAMINE AS SEDATIVE AGENTS IN PAEDIATRIC ORTHODONTIC EXTRACTIONS
ABSTRACT
Procedural fear is a major concern for the paediatric dentist and the patients, and so a variety of
techniques are employed to improve cooperation during dental treatments. These methods include the
use of voice control, intimidation, restraints as well as sedation. Indications for use of sedation during
dental procedures include uncooperative patients, painful procedures and mentally handicapped
patient. Studies have shown that the use of sedation is effective in allaying anxiety during treatments,
thus leading to better cooperation from the patients. This study was designed to compare the
effectiveness of oral Midazolam and oral Ketamine as sedative agents for paediatric dental sedation
using the Ramsey Sedation Score and Frankl behaviour rating scale.
This prospective, double blind study was conducted among ASA I and II children between the ages
of 2–11 years, scheduled for elective dental extractions under sedation in the dental department of
Lagos State University Teaching Hospital (LASUTH) following ethical approval. Written informed
consent was obtained from the parents of all the patients.
A total of one hundred and four (104) patients were randomized into two groups of 52 patients each
by balloting using an opaque envelope method. The patients were fasted according to the ASA
guidelines and Group A patients received ketamine orally at the dose of 7.5 mg kg-1 body weight,
while group B patients received midazolam orally at dose of 0.75 mg kg-1. The intravenous forms of
both drugs were formulated in apple juice and administered orally. Extractions were carried out after
the patients achieved a Ramsay sedation score of 3. The behaviour of the patients during the procedure
were scored using the Frankl behaviour rating scale.
The mean time to achieve a Ramsay sedation scale score of 3 was significantly shorter for oral
ketamine (24.25 ± 5.55 minutes) than oral midazolam (28.79 ± 5.75 minutes); p<0.001. The median
score of the behaviour of patients using Frankl behaviour rating scale was 3 (range: 1.0-4.0) with oral
ketamine versus 3 (range: 2.0-4.0) for oral midazolam (p = 0.026). The mean time of response to
stimulus in the recovery room was similar between the two groups; oral midazolam (61.60 ± 11.46
minutes) versus oral ketamine (61.17 ± 14.11minutes); p=0.867. The mean discharge time was shorter
with oral midazolam (62.81 ± 13.64 minutes) than oral ketamine (78.46 ± 14.48 minutes); p<0.001.
Tolerance to local anaesthesia injection using the improvised Dental practitioner’s adequacy of
sedation assessment was better with ketamine 4.0(1.0-4.0) versus midazolam 3.0(1.0-4.0); p=0.012.
Among the dental surgeons, ketamine was acceptable to 90.4% compared to 98.1% in the midazolam
group (p=0.093). Both drugs were acceptable to the parents of the children with ketamine 94.2%
compared to midazolam 98.1% (p=0.309).
The mean heart rate during sedation was higher with ketamine (119.15 ± 20.64 bpm) than oral
midazolam (111.96 ± 14.27 bpm), p<0.041. Similarly, the mean mean arterial blood pressure (MAP)
during sedation was higher with ketamine (90.35 ± 14.05 mmHg) than oral midazolam (76.26 ± 11.49
mmHg), p<0.001. The mean oxygen saturation during sedation was similar between the 2 groups
(ketamine 99.42 ± 0.61% versus oral midazolam 99.37 ± 1.01%; p = 0.552) and midazolam caused a
transient depression of peripheral oxygen saturation to 92%. None of the children required
supplemental oxygen during the study.
Side effects were more prominent in the ketamine group with vomiting occurring in 11.5%,
nystagmus 26.9%, somnolence 28.8% and hyper-secretion in 17.3% of the patients.
In conclusion, this study observed that although oral ketamine had a faster onset than oral midazolam,
both medications were effective in achieving adequate sedation for dental extraction among the
children studied. However, side effects were more prominent with ketamine while recovery was faster
and smoother with midazolam making it a more suitable drug for day case procedures.
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