Comparison of Efficacy in Sedation of Oral Melatonin, Intranasal Midazolam, and Inhaled Nitrous Oxide in Children Aged 4 to 7 Years: A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To comparatively evaluate the efficacy of different premedication agent in anxious children under oral melatonin, intranasal midazolam and nitrous oxide sedation in age group of 4 to 7 years during local anaesthetic administration.
Study Overview
Brief Summary
AIM- To comparatively evaluate theefficacy of different premedication agent in anxious children under oral melatonin,intranasal midazolam and nitrous oxide sedation in age group of 4 to 7 yearsduring local anaesthetic administration.
Material & Methodology- In a randomized study, 60children with age group 4 to 7 with Frankl’s behavior rating scale 2 and 3,received premedication, Group A- 3 mg/kg per dose of Oral melatonin 60 minutebefore the procedure (n=20), Group B- 0.2 mg/kg intranasal midazolam 60 minutebefore the local anaesthetic administration (n=20), Group C- preadjustedmixture of nitrous oxide–oxygen sedation was administered in the concentrationof 30–70% using Matrx Porter Digital Relative analgesia machine (n-20).
Subjectivepain perception during injection was measured using Wong Baker Faces PainRating Scale and objective pain by sound, eye, body movement rating scale andModified Dental Anxiety Scale score before and after local anaesthesiaadministration, patient satisfaction and comfort levels scores.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 4.00 Year(s) to 7.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.INCLUSION CRITERIA:.
- •a) Children between 4 and 7 years old. b)Need for local anesthesia for dental, minor surgical, or other procedures where the child might not cooperate without sedation. c)Children with no systemic disease d)No known allergies or contraindications to the sedative drugs planned for use.
Exclusion Criteria
- •2.EXCLUSION CRITERIA:.
- •a)Children below 4 and above 7 years old. b)Children with severe systemic diseases. c) Dental treatment not requiring injectable LA. d)Subjects exhibiting positive behaviour.
Outcomes
Primary Outcomes
To comparatively evaluate the efficacy of different premedication agent in anxious children under oral melatonin, intranasal midazolam and nitrous oxide sedation in age group of 4 to 7 years during local anaesthetic administration.
Time Frame: In a randomized study, 60 children with age group 4 to 7 with Frankl’s behavior rating scale 2 and 3, received premedication, Group A- 3 mg/kg per dose of Oral melatonin 60 minute before the procedure (n=20), Group B- 0.2 mg/kg intranasal midazolam 60 minute before the local anaesthetic administration (n=20), Group C- preadjusted mixture of nitrous oxide–oxygen sedation was administered in the concentration of 30–70% using Matrx Porter Digital Relative analgesia machine (n-20).
Secondary Outcomes
- comparatively evaluate the efficacy of different premedication agent in anxious children under oral melatonin, intranasal midazolam and nitrous oxide sedation in age group of 4 to 7 years during local anaesthetic administration.(1.To determine the efficacy of oral melatonin to intranasal midazolam)