Sublingual Ketorolac Compared to Intranasal Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Bilateral Myringotomy

Study Overview
=================
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

Official Title
-----------------
A Prospective Randomized Trial of Sublingual Ketorolac Compared to Intranasal Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Bilateral Myringotomy

Conditions
-----------------
Elective Bilateral Myringotomy

Intervention / Treatment
-----------------
* Drug: intranasal dexmedetomidine
* Drug: sublingual ketorolac


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intranasal dexmedetomidine<br>this group is planned for intranasal dexmedetomidine | Drug: intranasal dexmedetomidine<br>* 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<br>|
| Active Comparator: sublingual ketorolac<br>this group is planned for sublingual ketorolac | Drug: sublingual ketorolac<br>* 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%<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of analgesia | The duration of analgesia,define as the time to the first demand for rescue analgesic | time from administering the study solution till the time for the first rescue analgesic] during first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score | Postoperative pain will be assessed by the CHEOP scale (Children's Hospital of Eastern Ontario Pain Scale) . | For 24 hours after surgery | 
| Heart rate |  | for 2 hours after the start of surgery | 
| systolic blood pressure |  | for 2 hours after the start of surgery | 
| Number of patients received rescue analgesics | Total number of children who required postoperative pain medication during the 24-h period will be registered | For 24 hours after surgery | 
| Degree of sedation | The degree of sedation will be assessed by using Ramsay scale | For 24 hours after surgery | 
| Nausea and vomiting |  | For 24 hours after surgery |