Comparison of the efficacy of intranasal atomised dexmedetomidine versus intranasal atomised ketamine as a premedication for sedation and anxiolysis in children undergoing spinal dysraphism surgery
A randomized controlled trial.
European Journal of Anaesthesiology
Submitted July 2024 by Dr Ben Blaise
Read by 238 Journal Watch subscribers
Study type:
This is a prospective randomised double blind trial in a single paediatric tertiary centre.
Methods:
64 children aged 1 to 10y referred for elective spinal dysraphism surgery.
Patients were randomly allocated to the intranasal atomised dexmedetomidine (2.5mcg/kg) or intranasal atomised ketamine (5mg/kg) groups. Premedication was given 30min before surgery.
The primary outcome was the level of sedation (using the University of Michigan Sedation Score). Secondary outcomes included ease of parental separation, intravenous cannulation, satisfactory mask acceptance and perioperative vitals.
Findings:
Better sedation was achieved in the dexmedetomidine group (UMSS 1.55 +/- 0.51 vs 1.13 +/- 0.34 at 20min; 2.32 +/- 0.6 vs 1.94 +/- 0.5 at 30min). There was no difference in ease of separation, cannulation and mask acceptance between the 2 groups. Heart rate was lower in the dexmedetomidine group at 10, 20 and 30 min but without clinical significance.
Take home message:
• Relevance of the study
a. Perioperative anxiety is a growing issue with some studies reporting up to 60% anxious patients in the immediate preoperative period.
b. Midazolam and dexmedetomidine are amongst the drugs widely used as premedication.
c. Focus on intranasal administration of these 2 drugs using a new device improving drug delivery.
• Recent research, evidence or study on the subject
2 papers per month published over the last 15 months on perioperative anxiety in children and premedication, exploring different drugs, ways of administering them, for different procedures, as well as effects on patient anxiety, clinical side effects (jarmo dynamic and respiratory) or organisational impact (staff, length of stay in PACU or before discharge).
• Strengths of the study
a. Robust methodology (prospective randomised double blind trial)
b. Investigation of the haemodynamic effects of dexmedetomidine
c. Well-designed trial, including power calculation, statistical analysis and recruitment targets were achieved,
d. Use of the mucosal atomisation device allowing a more efficient administration of intranasal premedication.
• Limitations of the study
a. Clinical relevance of the difference in UMSS found between the 2 groups. Although dexmedetomidine provides a statistically significant difference in terms of sedation compared to midazolam, there was no difference observed in terms of ease of parental separation, cannulation or mask acceptance.
b. Authors didn’t use the modified Yale Preoperative Anxiety Scale (usually considered as the gold standard for pre operative anxiety evaluation).
c. Authors’ self-declared limitations: single centre study with small sample size, absence of age stratification, baseline anxiety of the patients
• Applicable to our practice?
Yes, these results should be easily transferrable to other procedures and hospitals. Having robust data on the intranasal use of midazolam and dexmedetomidine is useful in children with behavioural issues likely to spit out any drug given orally.
