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

Not Applicable

Withdrawn

• Conditions: Elective Bilateral Myringotomy
• Interventions: Drug: sublingual ketorolac; Drug: intranasal dexmedetomidine

• Registration Number: NCT03742180
• Lead Sponsor: Mansoura University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-15
• Primary Completion: 2019-04-30
• Study Completion: 2019-05-15
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-04
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• ASA physical status I- II.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sublingual ketorolac	sublingual ketorolac	this group is planned for sublingual ketorolac
intranasal dexmedetomidine	intranasal dexmedetomidine	this group is planned for intranasal dexmedetomidine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Nausea and vomiting	For 24 hours after surgery
Heart rate	for 2 hours after the start of 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
Degree of sedation	For 24 hours after surgery	The degree of sedation will be assessed by using Ramsay scale
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) .
systolic blood pressure	for 2 hours after the start of surgery

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansourah, DK, Egypt