Preoperative Sedation
Conditions
Brief summary
This study is to be carried out to compare nebulized and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatrics.
Detailed description
This study is to be carried out to compare nebulized midazolam and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatric surgical patients. In Pediatric Specialized Hospital, Cairo University 72 pediatric patients scheduled for undergoing general or uro-surgical operations under general anesthesia will be included in this double-blinded study. Patients will be randomly assigned into two equal groups, each group including 36 patients. In one group 36 children will receive nebulized midazolam 0.2 mg/kg in 3 ml normal saline plus 5 ml clear juice (orally) 30 min before undergoing general anesthesia. In the other group 36 children will receive oral midazolam 0.5 mg/kg in 5 ml clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing GA. level of sedation will be compared between both groups
Interventions
DRUGMidazolam nebulized
midazolam nebulized
midazolam given oral
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients from 2 to 6 years undergoing uro-surgery and general surgical procedures. * Duration of surgery 1-2 hours * Gender eligible for the study: both. * ASA I-II.
Exclusion criteria
* ASA III-IV * Patients with elevated levels of serum ALT, Creatinine. * Emergency surgeries. * Pre-existing neurologic disease. * Parent refusal. * History of allergy to midazolam. * Patients with atopy or a history of asthma. * Lengthy procedures of more than 2 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time required to reach a satisfactory level of sedation | from time of applying the nebulizer until 30 minutes | time to reach ramsay sedation score 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of separation from parents | from 30 minutes after receiving midazolam till transfer to operating room | using ease of separation and induction scoring system: 1. Excellent: patient unafraid, cooperative, or asleep 2. Good: slight fear and/or crying, quiet with reassurance 3. Fair: moderate fear and crying, not quiet with reassurance 4. Poor: crying, need for restraint |
| acceptability of Face mask by grading systen | from time of applying face mask till time of getting asleep at 1 minute intervals | Facemask acceptance was graded as poor (terrified, crying, and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured), or excellent (unafraid, cooperative, and accepts mask readily) |
| Recovery time | time from discontinuation of anesthesia until regaining baseline sedation score at 5 minute intervals | time to recover |
| Acceptability of method of administration of midazolam by a grading system | from time of giving midazolam oral or nebulized till 30 minutes | Facemask acceptance will be graded as poor (terrified, crying, and combative),fair (moderate fear of mask not calmed with reassurance),good (slight fear of mask, easily reassured), or excellent (unafraid, cooperative, and accepts mask readily). |
| changes in oxygen saturation | from start of sedation till 1 hour postoperative at 5 minute intervals | changes in oxygen saturation |
| changes in heart rate | from start of sedation till 1 hour postoperative at 5 minute intervals | changes in heart rate changes in heart rate (beats per minute) |
| Changes in mean arterial blood pressure | from start of sedation till 1 hour postoperative at 5 minute intervals | Changes in mean arterial blood pressure measured in mmHg |
Countries
Egypt
Outcome results
None listed