Elective Bilateral Myringotomy
Conditions
Brief summary
The investigators aim to compare intranasal dexmedetomidine in a dose of 1ug.kg-1 with sublingual ketorolac in a dose of 1mg.kg-1 on postoperative behaviour in those children undergoing BMT during their PACU stay
Detailed description
Data were analyzed through SPSS (Statistical Package for Social Sciences), Program version 22. Distribution of data was first tested by Shapiro test. Data were presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, an unpaired t-test was used to compare between mean values of both groups. For pain and sedation scores, Mann Whitney U test was used. Fisher's exact test was used for comparison of categorical data. The P value ≤ 0.05 was considered as the level of statistical significance. A prior G power analysis was done. Using the results obtained from previous studies (14- 18) and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the study 80 %), a sample size of 60 patients per group was calculated. A drop out 10% of cases is expected, so; 33 cases per group will be required
Interventions
DRUGintranasal dexmedetomidine
The patient will receive intranasal dexmedetomidine in a dose of 1ug.kg-1 in a volume of 1 ml was dripped into both nostrils using a 1-mL syringe, with the patients in the recumbent position plus 1ml sublingual 0.9% saline
DRUGsublingual ketorolac
The patient will receive sublingual ketorolac in a dose of 0.5 mg.kg-1 in a volume of 1 ml and 1 ml intranasal saline 0.9%
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status I- II.
Exclusion criteria
* History of ketamine * History of NSAID * History of allergies * Any bleeding disorders * History of GIT bleeding * Those who will undergo other procedures in addition to bilateral myringotomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| duration of analgesia | time from administering the study solution till the time for the first rescue analgesic] during first 24 hours | The duration of analgesia,define as the time to the first demand for rescue analgesic |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | for 2 hours after the start of surgery | — |
| systolic blood pressure | for 2 hours after the start of surgery | — |
| Postoperative pain score | For 24 hours after surgery | Postoperative pain will be assessed by the CHEOP scale (Children's Hospital of Eastern Ontario Pain Scale) . |
| Degree of sedation | For 24 hours after surgery | The degree of sedation will be assessed by using Ramsay scale |
| Nausea and vomiting | For 24 hours after surgery | — |
| Number of patients received rescue analgesics | For 24 hours after surgery | Total number of children who required postoperative pain medication during the 24-h period will be registered |
Countries
Egypt
Outcome results
None listed