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Preventing febrile seizures in children with oral diazepam: can a controlled trial truly be "double-blind?"
N P Rosman1, L M Douglass, J L Paolini
1Department of Pediatrics, Division of Pediatric Neurology, The Floating Hospital for Children, New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts 02111, USA.
Insights
Parents often guessed their child's treatment group in a double-blind trial for febrile seizures. This parental awareness of diazepam or placebo treatment may affect study outcomes.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
Background:
- Double-blind clinical trials are crucial for evaluating treatment efficacy.
- Maintaining participant and caregiver "blindness" is essential for unbiased results.
Purpose of the Study:
- To assess parental "blindness" in a randomized, double-blind trial for febrile seizures.
- To investigate factors influencing parental guessing of treatment allocation.
Main Methods:
- A randomized, double-blind trial involving 406 children with febrile seizures treated with oral diazepam or placebo.
- Post-treatment interviews with 192 families to determine if parents guessed their child's treatment group and why.
Main Results:
- 69% of parents in the diazepam group correctly guessed their child's treatment.
- Only 19% of parents in the placebo group guessed correctly.
- Side effects and treatment efficacy/failure were key factors influencing parental guesses.
Conclusions:
- Parental awareness of active drug (diazepam) or placebo treatment can compromise "blindness" in pediatric trials.
- This compromised blindness may impact adherence to study protocols.
- Safeguards are necessary to mitigate parental bias and ensure the validity of double-blind clinical trial results.
Objective:
To determine in a randomized, double-blind, clinical drug trial in children whether parental "blindness" is maintained.
Study Design:
Oral diazepam or placebo was given for fevers to 406 children with at least one previous febrile seizure. Later, 192 of these families (102 diazepam, 90 placebo) were contacted and asked: (1) Did you give your child the study medicine for fevers? (2) Do you think you knew your child's treatment group (diazepam or placebo)? (3) If you think you knew, why?
Results:
In the group of children randomly assigned to receive diazepam, 69% of their parents guessed correctly. In the group assigned to receive placebo, only 19% of parents guessed correctly. Parental opinion was influenced mostly by the presence or absence of side effects, and treatment efficacy or failure was the next most important factor.
Conclusion:
Because in a double-blind clinical trial, many parents can correctly guess that their child is receiving active drug, this may influence compliance with the protocol. Thus safeguards are needed to reduce parental bias that can invalidate the results of double-blind clinical trials.
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