The purpose of this study is to assess the effectiveness of nitrous oxide/oxygen administration in reducing the discomfort of intranasal midazolam administration for moderate sedation for dental procedures.
This study will determine the effectiveness of two different concentrations of nitrous oxide for reducing the pain of intranasal midazolam when given for subjects already planned for moderate sedation for completion of dental procedures in the pediatric dental clinic. Moderate dental sedation is useful because it helps relieve anxiety and make the dental procedure less memorable and more comfortable for the patient. Sedation appointments typically go smoothly when the patient is calm rather than when the patient is upset. Giving midazolam through the nose can be painful and the dental provider risks upsetting a patient and causing the sedation appointment to fail. Therefore, the goal of this study is to test whether nitrous oxide administration is effective in reducing the pain from intranasal midazolam administration. The effectiveness will be measured by the primary outcome of heart rate pre- and post- midazolam administration for the two randomly assigned study arms. The first study arm will be given 30% nitrous/70% oxygen and the second study arm will be given 70% nitrous/30% oxygen prior to the midazolam administration. The secondary outcome will compare subject, dental provider, and the parent/guardian answers to questions regarding the subject's experience pre- and post- midazolam administration. The investigators hypothesize lower changes in heart rate and less pain reported following midazolam administration in subjects given 70% nitrous oxide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Nitrous oxide will be given prior to determine if it reduces pain from intranasal midazolam administration. Nitrous oxide is a minimal sedation drug used as an inhaled gas to reduce anxiety and produce anxiolysis and analgesia during dental procedures.
Intranasal midazolam will be given after nitrous oxide administration.
Children's Hospital Colorado
Aurora, Colorado, United States
RECRUITINGHeart rate
Measured in beats per minute with range from 50-190 bpm. A great change in heart rate indicates more pain and less effect of the nitrous oxide. Heart rate is an autonomic reflex to determine the effect of mental and physical stressors including painful stimuli. The participants resting heart rate will be compared to the heart rate immediately after intranasal midazolam administration for a change in heart rate value.
Time frame: through the study completion, an average of 2 years
Visual analog scales (VAS) for pain
Scale from 1 (no pain) to 10 (most possible pain). A higher score indicates greater pain. VAS will be obtained from the subjective standpoint of the parent/guardian of the parent and the dental provider during time points before and after the administration of intranasal midazolam.
Time frame: through the study completion, an average of 2 years
Visual analog scales (VAS) for fear
Scale from 1 (no fear) to 10 (very fearful). A higher score indicates greater fear. VAS will be obtained from the subjective standpoint of the parent/guardian of the parent and the dental provider during time points before and after the administration of intranasal midazolam.
Time frame: through the study completion, an average of 2 years
Wong-Baker Faces scale for pain
Scale from 0 (no hurt) to 10 (hurts worst). A higher score indicates more pain. Wong-Baker Faces scale will be recorded from the subjective standpoint of the participant.
Time frame: through the study completion, an average of 2 years
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