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

Elective Bilateral Myringotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03742180
• Other study ID #: R/18.06.212
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 15, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Elective Bilateral Myringotomy

Intervention

Drug:
• intranasal 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
• sublingual 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%

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Heart rate		for 2 hours after the start of surgery
Secondary	systolic blood pressure		for 2 hours after the start of surgery
Secondary	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
Secondary	Degree of sedation	The degree of sedation will be assessed by using Ramsay scale	For 24 hours after surgery
Secondary	Nausea and vomiting		For 24 hours after surgery