Comparative evaluation of sedative, anxiolytic and post-operative effects of oral melatonin andnitrous oxide inhalation sedation in 5 to 8 year old children - an ELISA based study.

NAME OF PRINCIPAL INVESTIGATOR: Dr. Shailja Sinha

Department of Pediatrics and Preventive Dentistry,

ITS CDSR, MURADNAGAR,

GHAZIABAD,

UP- 201206

 You are being invited to participate in a researchstudy.

 Study Title: Comparativeevaluation of sedative, anxiolytic and post-operative effects of oral melatoninand nitrous oxide inhalation sedation in 5 to 8-year-old children - AnELISA-based study.

 Invitation Paragraph: I would like to invite you to take part in a research study.Before you take part in this research study, we wish to explain the study toyou and give you the chance to ask questions. Please read carefully theinformation provided here. If you agree to participate, please sign theinformed consent form.

 **Introduction:**This information sheet describes the purpose, procedures, benefits, anddiscomforts of the study and your right to withdraw from the study at any pointin time.

 Purpose: Thepurpose of this study is to compare sedative, anxiolytic, and post-operativeeffects of oral melatonin and nitrous oxide inhalation sedation in 5 to 8 yearold children immediately after administration of local anesthesia for invasivedental procedures.

 Study Procedure: Your relevant clinical history will be recorded; a clinicalexamination will be conducted and findings will be noted. After taking writteninformed consent, the child will be administered Oral Melatonin Syrup orNitrous Oxide Inhalation Sedation followed by the collection of his/her salivafor Salivary Cortisol assessment using an ELISA kit both before and immediatelyafter the administration of IANB for primary mandibular molar indicated forextraction. The costs of the tests included in the protocol that form theroutine radiological, and clinical investigations for the management of thepatient, shall be borne by the patient. The cost of any additionalinvestigations that are not part of routine diagnostics shall be borne by thePrincipal investigator/ Concerned Department/ Institute and should be free forthe patient.

 **Risks:**There are noexpected risks of saliva collection. The expected risk of Oral Melatonin andNitrous Oxide Inhalation Sedation includes minimal side effects such as milddizziness and light-headedness. In case of any adverse event/ injuries, theparticipants shall be treated without any further charges for the adverseevent. However, there shall be no financial compensation to the patient fromthe institution or Principal Investigator.

 **Benefits:**The information obtained shall be used to compare the effects of OralMelatonin Syrup and Nitrous Oxide Sedation for the pharmacological behaviormanagement of the child. This would help to increase our knowledge about theuse of Oral Melatonin in Pediatric Dentistry.

 **Confidentiality:**Records of your participation will be kept confidential. Any publicationof data will not identify you by your name. By signing the consent form, youauthorize the sharing of your study-related records with the regulatoryauthorities and the Institutional Ethical Committee.

 **Information regarding withdrawal:**You have the right to withdraw yourself from the study at any timeduring the course of study without any prejudice to your or your family’s rightto undergo future treatment at I.T.S. CDSR, Muradnagar.

 There is no risk or complications associated withthis study and in case of any doubt, you can contact at 7001573934.