Comparison of nasal administration of two sedative drugs dexmedetomidine and fentanyl for sedation before surgery in children
- Conditions
- ASA I/II Patients posted For Elective Surgery
- Registration Number
- CTRI/2018/04/013050
- Lead Sponsor
- Bhagat Phool Singh Government Medical College For Women
- Brief Summary
Childrenare more anxious and fearful due to their limited cognitive capabilities, lackof understanding of health care system and lack of self-control. Premedicationhelp to alleviate the stress and fear of treatment as well as to easechild-parent separation and promote smooth induction of anesthesia. Theintramuscular, intravenous, subcutaneous and intraosseous routes provideoptimal drug delivery, but they are painful and children dislike the needleprick. Multiple agents have been used to treat pre-operative anxiety and stress.New drugs such as the α2 agonists have been introduce as an alternative forpremedication in pediatric patients. In our study we aim to compare the effectof intranasal dexmedetomidine and intranasal fentanyl in pediatric patientsposted for elective surgery. A total of 88 patients will be randomly allocatedinto 2 groups with 44 patients in each group. Group D will receive intranasaldexmedetomidine 1µgm/kg and group F will receive intranasal fentanyl 1.5µgm/kg, 45 minutes prior to induction of anesthesia. Patients will be monitoredpre-operatively for vitals parameters including heart rate, blood pressure,oxygen saturation and sedation and child parent separation score.Intra-operatively vitals and post-operatively behavior and sedation score willalso be monitored. Possible side- effects of these agents will be monitored andmanaged. Thereafter, comparison will be made among the two groups based on thedata collected. The different variables and occurrence of side effects, if any,would also be noted and compared amongst all groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 88
- 1.Children of American society of Anesthesiologists (ASA) grade I/II/ patients 2.Age group:- 2 to 10 yrs of age of all genders.
- 3.Weight ≤ 25kg.
- 4.Elective surgical procedures under General Anesthesia.
- 5.Parents and guardian willing to provide their voluntary written informed consent form for participation in the study.
- 1.Parents and guardian not willing to participate in the present study.
- 2.History of allergy and hypersensitivity to dexmedetomidine / fentanyl.
- 3.Presence of upper respiratory tract infection and nasal pathology.
- 4.Patients having delayed milestones and who are mentally challenged.
- 5.Patients with any cardiac/respiratory disease.
- 6.Surgery lasting for more than 90 minutes will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To determine the time of onset and duration of sedation. 1.Time of onset and duration of sedation in 45 minutes of premedication and 3 hours of post surgery | 2.Anxiety by child parent separation score at end of 45 minutes of premedication | 3.Post-operative behaviour score at end of surgery | 4.post-operative sedation score at the end of surgery and till 3 hours after surgery 2.To determine the level of anxiety by child parent separation score. 1.Time of onset and duration of sedation in 45 minutes of premedication and 3 hours of post surgery | 2.Anxiety by child parent separation score at end of 45 minutes of premedication | 3.Post-operative behaviour score at end of surgery | 4.post-operative sedation score at the end of surgery and till 3 hours after surgery 3.To determine post-operative sedation and behavior score 1.Time of onset and duration of sedation in 45 minutes of premedication and 3 hours of post surgery | 2.Anxiety by child parent separation score at end of 45 minutes of premedication | 3.Post-operative behaviour score at end of surgery | 4.post-operative sedation score at the end of surgery and till 3 hours after surgery
- Secondary Outcome Measures
Name Time Method 1.To determine hemodynamic parameter like heart rate, blood pressure, mean arterial pressure, SpO2 in each group. 2.To determine the side effect in each group if any.
Trial Locations
- Locations (1)
Bhagat Phool Singh Government Medical College For Women
🇮🇳Sonipat, HARYANA, India
Bhagat Phool Singh Government Medical College For Women🇮🇳Sonipat, HARYANA, IndiaMohit PariharPrincipal investigator9887363806drmohitparihar09@gmail.com