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

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ClinicalTrials.gov Identifier: NCT03742180
Recruitment Status : Enrolling by invitation
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Elective Bilateral Myringotomy Drug: intranasal dexmedetomidine Drug: sublingual ketorolac Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Prospective Randomized Trial of Sublingual Ketorolac Compared to Intranasal Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Bilateral Myringotomy
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intranasal dexmedetomidine
this group is planned for intranasal dexmedetomidine
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

Active Comparator: sublingual ketorolac
this group is planned for sublingual ketorolac
Drug: 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%




Primary Outcome Measures :
  1. duration of analgesia [ Time Frame: 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 :
  1. Postoperative pain score [ Time Frame: For 24 hours after surgery ]
    Postoperative pain will be assessed by the CHEOP scale (Children's Hospital of Eastern Ontario Pain Scale) .

  2. Heart rate [ Time Frame: for 2 hours after the start of surgery ]
  3. systolic blood pressure [ Time Frame: for 2 hours after the start of surgery ]
  4. Number of patients received rescue analgesics [ Time Frame: For 24 hours after surgery ]
    Total number of children who required postoperative pain medication during the 24-h period will be registered

  5. Degree of sedation [ Time Frame: For 24 hours after surgery ]
    The degree of sedation will be assessed by using Ramsay scale

  6. Nausea and vomiting [ Time Frame: For 24 hours after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742180


Locations
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Egypt
Mansoura University
Mansourah, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University

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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03742180     History of Changes
Other Study ID Numbers: R/18.06.212
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors