Nebulized Dexmedetomidine VS ODF Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Day Surgery

Nebulized Dexmedetomidine VS Oro-dispersible Film Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Outpatient Surgeries: A Randomized Controlled Double-blinded Study

The goal of this clinical trial is to compare between the effect of nebulized dexmedetomidine and the effect of oral dispensable film (ODF) melatonin in controlling perioperative anxiety and post operative emergence agitation and their effect on the overall surgical experience.in pediatric patients undergoing day case surgery.

Study Overview

• Status: Recruiting
• Conditions: Emergence Agitation; Anxiety Acute
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Melatonin; Drug: Placebo

Detailed Description

All patients will be admitted on the day of the surgery and will be instructed to fast 6 hours before surgery for older patients, as for breast fed patients, they will be instructed for 4 hours for breast feeding and for formula fed patients they will be instructed to fast for 6 hours as recommended by the American society of anesthesiologists. Preoperative assessment will be done before surgery by one of the members of the team who will make sure that the inclusion and exclusion criteria of the patients are considered, and baseline vital signs will be recorded. According to randomization that will be done by envelop concealed allocation , the drug will be administered to the patients by a researcher who will not participate in the evaluation of the patients 30 mins before transfer to the operation room (OR): each group will receive the intervention drug Parents are not allowed to accompany their children to the OR according to the hospital policy. On arrival to the OR department the Parental separation anxiety scale (PSAS) will be calculated on entering the operation room standard monitoring will be commenced including ECG, non-invasive blood pressure and pulse oximetry and baseline measurement will be recorded. Inhalational induction will be then started with sevoflurane and mask acceptance will be calculated according to the mask acceptance scale (MAS) intravenous cannulation will be then established after which each patient will receive 1-2 mg/kg Propofol, 1 µg/kg fentanyl to attenuate the stress of intubation and 0.5mg/kg atracurium after tracheal intubation anesthesia will be maintained with sevoflurane 2-4 MAC During the length of the operation vital data will be recorded at 5 minutes interval. all patients will receive IV paracetamol 15mg/kg and patient would receive 1 µg/kg fentanyl as a rescue dose if vital data increased by >20% of the baseline.

after the completion of surgery extubating will be performed after meeting extubation criteria and patient will be discharged to post-anesthesia care unit (PACU) in for the first 15 min after admission to PACU the post anesthesia emergence agitation will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED) during the stay in PACU pain will also be assessed by using FLACC score Discharge from PACU will be done after meeting discharge criteria and the time of discharge will be documented. After discharge pain score will be measured using FLACC score at 15, 30, 60 minutes interval postoperative and the total combustion of postoperative analgesics will be calculated as well as the time of discharge from the hospital

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nada M Aboelrouse, masters; Phone Number: 00201003371346; Email: nadaaboelrouse21@gmail.com
• Study Contact Backup: Name: Mohamed A Tolba, MD; Phone Number: 0020115 6622298; Email: Mohamedtolba@med.asu.edu.eg

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 11213
      • Recruiting
      • Ain Shams University Hospital
      • Contact: Nada M Aboelrouse, masters; Phone Number: 00201003371346; Email: nadaaboelrouse21@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of American Society of Anesthesiologists (ASA) physical status I & II
• both genders,
• ≥ 2 to 10 years,
• scheduled for elective day case surgery under general anesthesia

Exclusion Criteria:

• parents' refusal for participation in the study
• ASA III and VI patients with history of chronic illness
• runny nose or upper respiratory tract infection
• Emergency surgeries with hemodynamic instability
• history of allergic reaction to dexmedetomidine or melatonin
• History of prematurity
• developmental delay
• central nervous system disorder,
• mental retardation,
• neurological or psychiatric illness that may be associated with anxiety and agitation (cerebral palsy, seizure, separation anxiety disorder, ADHD etc.).
• treatment with anticonvulsants and sedatives

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group D; will receive placebo ODF and nebulized dexmedetomidine (Precedex™ rxlist)	Drug: Dexmedetomidine; receive placebo ODF and 3 µ/kg nebulized dexmedetomidine (Precedex™ rxlist) prepared in 0.9% normal saline to a final volume of 3ml. Nebulization was performed using a wall nebulizer and wall oxygen source on 4 l/min.; Other Names: Precedex™ rxlist
Active Comparator: group M; will receive placebo nebulizer and ODF melatonin (metacyst ™ nerhadou)	Drug: Melatonin; will receive placebo nebulizer and 0.4mg/kg of ODF melatonin (metacyst ™ nerhadou) orally allowing the film to dissolve in the patients Oro mucosal lining; Other Names: metacyst ™ nerhadou
Placebo Comparator: group C; will receive placebo ODF and placebo 0.9% normal saline nebulizer	Drug: Placebo; placebo ODF and 0.9% normal saline nebulizer; Other Names: normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perioperative anxiety	perioperative anxiety will be measured by using Parental separation anxiety scale (PSAS) will be calculated according to the following: Behavior of the child during separation from parents will be Excellent if the Patient unafraid, cooperative, or asleep will be given the score of (1); Behavior of the child during separation from parents will be Good if the patient is Slightly afraid/crying, quiet with reassurance will be given the score (2); Behavior of the child during separation from parents will be Fair if the patient is Moderately afraid and crying not quit with reassurance with the score (3); Behavior of the child during separation from parents will be poor if the patient is Crying, need for restraint with the score (4) the score of (1) means excellent response , score of (2) means good response , score of (3) means fair response and score of (4) means poor response	during the patient separation from the caregiver just as the child is going to the operating theater

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mask acceptance	calculated according to the mask acceptance scale (MAS) as following : if the Child is calm, cooperative, or asleep the score will be (1) if the child is in Moderate fear of the mask Manageable with reassurance the score will be(2) if the child Cries, combative and needs restraining the score will be (3) score of (1) means excellent response ,score of (2) means fair response and score of (3) means poor response	during the mask introduction to start inhalational induction of anesthesia with sevoflurane before skin incision
post anesthesia emergence agitation	will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED) with score 1= calm , 2= not calm but could be easily consoled , 3= moderately agitated or restless and not easily calmed , 4 = combative , excited , thrashing around	first 15 minutes after admission to post- anesthesia care unit
pain score	using Face, leg, activity, cry and Consolability score With score of 0 meaning no pain and requires no intervention and score of 10 indicating the worst imaginable pain requiring rescue analgesia	during hospital stay up to 3 hours

Collaborators and Investigators

• Sponsor: nada moahmed aboelrouse
• Investigators: Study Chair: Sohair Abbas, MD, Ain Shams University, Anesthesia department; Study Director: Ramy Mahrose, MD, Ain Shams University, Anesthesia department; Study Director: Wessam Zaher, MD, Ain Shams University, Anesthesia department

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2023
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: February 19, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Anxiety Disorders; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Protective Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Antioxidants; Dexmedetomidine; Melatonin
• Other Study ID Numbers: FWA 000017585

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No