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Midazolam nasal spray reduces procedural anxiety in children
G Ljungman1, A Kreuger, S Andréasson
1Unit for Pediatric Oncology and Hematology, Department of Women's and Children's Health, Uppsala University Children's Hospital, Uppsala, Sweden. gustaf.ljungman@pediatrik.uu.se
Insights
Intranasal midazolam spray effectively reduced anxiety and procedure problems in children undergoing cancer treatment. While parents and nurses noted pain reduction, children reported less significant pain relief, with nasal discomfort being a notable side effect.
Area of Science:
- Pediatric Oncology
- Pain Management
- Sedation
Background:
- Anxiety and pain are significant challenges during pediatric procedures, particularly in pediatric oncology.
- Conscious sedation is employed when non-pharmacological methods fail to manage children's procedural fear.
Purpose of the Study:
- To evaluate the efficacy of intranasal midazolam in reducing anxiety, discomfort, pain, and procedure-related issues in children undergoing needle insertion for central venous port access.
- To compare intranasal midazolam with a placebo in a pediatric oncology setting.
Main Methods:
- A randomized, double-blind, placebo-controlled, crossover study involving 43 pediatric cancer patients.
- Intranasal midazolam spray (0.2 mg/kg) was administered and compared against a placebo.
- Efficacy was assessed using visual analog scale questionnaires completed by children, parents, and nurses.
Main Results:
- Parents and nurses reported significant reductions in anxiety, discomfort, and procedure problems with midazolam, along with pain reduction.
- Children reported decreased anxiety and procedure problems, but pain and discomfort reduction was not statistically significant.
- Nasal discomfort affected approximately 45% of patients and was the primary reason for dropouts (19%).
Conclusions:
- Intranasal midazolam spray provides relief for anxious children facing procedures like central venous port access and venous cannulation.
- Potential limitations include nasal discomfort, suggesting alternative routes like rectal or oral administration for some patients.
Objective:
Anxiety and pain even in minor procedures are still great problems in pediatrics, not least in pediatric oncology. Conscious sedation is indicated when other means to overcome a child's fear fail. The aim of this study was to investigate whether intranasal administration of midazolam given before insertion of a needle in a subcutaneously implanted central venous port could reduce anxiety, discomfort, pain, and procedure problems.
Method:
Forty-three children with cancer participated in this randomized, double-blind, placebo-controlled, crossover study in which nasal administration of midazolam spray,.2 mg/kg body weight, was compared with placebo. Children, parents, and nurses completed a visual analog scale questionnaire to evaluate efficacy.
Results:
Parents and nurses reported reduced anxiety, discomfort, and procedure problems for children in the midazolam group and would prefer the same medication at next procedure. They also reported pain reduction. Children reported reduced anxiety and procedure problems but reduction of pain and discomfort was not significant. No serious or unexpected side effects occurred. Nasal discomfort was the most common side effect (17/38 approximately 45%) and the primary reason for dropouts (8/43 approximately 19%). Anxiety varied with age but not with gender. When anxiety increased, the differences between midazolam and placebo increased.
Conclusion:
Nasal midazolam spray offers relief to children anxious about procedures, such as insertion of a needle in a subcutaneously implanted intravenous port, venous blood sampling, venous cannulation, etc. Its use, however, may be limited by nasal discomfort in some patients for whom rectal and oral routes might be alternatives.
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