Anxiety Preoperative, Emergence Delirium
Conditions
Brief summary
Comparative study between nebulised dexmedetomidine and nebulized midazolam in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries
Detailed description
Dexmedetomidine is widely used in children and is replacing midazolam as the drug of choice for preoperative anxiolysis and sedation. However, there are limited studies comparing nebulized route in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries
Interventions
DRUGNebulised Dexmeditomidine
premedication by dexmeditomidine 3mcg/kg in children undergoing lower abdominal surgeries
DRUGNebulised Midazolam
premedication by nebulised midazolam 0.3mg/kg in children undergoing lower abdominal surgeries
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 3-8 years * ASA I&II * Undergoing lower abdominal surgeries for example hernia repair and circumcision
Exclusion criteria
* Children with chest infection, respiratory disease, cardiac disease * Children with mental or physical disabilities, treatment with sedatives and anticonvulsants * Parental refusal * Allergy to study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| level of preoperative anxiety | 30 minutes after drug administration | The level of anxiety of the child during separation from parents according to Parental separation anxiety scale (PSAS), with a 4-point scale as: 1=easy separation; 2=whimpers, but is easily reassured, not clinging; 3=cries and cannot be easily reassured, but not clinging to parents and 4=crying and clinging to parents |
| Incidence of emergence delirium | immediate postoperative | Incidence of emergence delirium, wake up behaviour will be assessed according to Watcha scale where Score is observed values as follows: 0= asleep, 1=calm, 2=crying but can be consoled, 3=crying but cannot be consoled, 4=agitating and thrashing around |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PONV | perioperative | Incidence of post-operative nausea and vomiting. |
| the level of sedation | 30 minutes after drug administration | The level of sedation when the child first seen in the operating room 30 minutes after sedation using Ramsey sedation scale |
| total fentanyl use | intraoperative | Total fentanyl use during operation |
| recovery time | up to 2 hours postoperative | Recovery time, time between laryngeal mask removal and discharge from recovery room. |
| hemodynamic changes | perioperative | number of participants experienced any hemodynamic changes if more than 20% change in mean arterial pressure (MAP) and Heart Rate (HR). |
Countries
Egypt
Outcome results
None listed