Intravenous Dexmedetomidin on Postoperative Pain After Hypospadias Repair in Children
Intrtavenous Ketorolac Versus Intravenous Dexmedetomidine for Postoperative Analgesia After Hypospadius Repair
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
This study aimed to evaluate the efficacy of intravenous ketorolac versus dexmedetomidine as analgesia after Hypospadias repair surgery to determine the optimal procedure for pain control and postoperative reduction of analgesic use
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 postoperative-pain
Started Jan 2022
Typical duration for phase_2 postoperative-pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 4, 2022
CompletedFirst Posted
Study publicly available on registry
January 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedJanuary 18, 2022
January 1, 2022
1.5 years
January 4, 2022
January 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total analgesic consumption in the first 24 hours after surgery
Total analgesic consumption in the first 24 hours after surgery
first 24 hours
Study Arms (2)
group 1
ACTIVE COMPARATORketorolac group: number = 30 patients , time : after intubation, dose 0.9 mg/kg
group 2
ACTIVE COMPARATORDexmedetomidine group: number : 30 patients, time : after intubation, dose 1 μg/kg
Interventions
This is a prospective randomised clinical study designed to assess the effect of intravenous ketorolac versus intravenous dexmedetomidin on postoperative pain after hypospadias repair in children
Eligibility Criteria
You may qualify if:
- ASA physical status I \& II.
- Age between 2 years \& 6 years old.
- Body weight below 30 Kg.
You may not qualify if:
- Any contraindications to any drug used
- patients refusal
- recurrent surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Gao J, Sun Z, Xiao Z, Du Q, Niu X, Wang G, Chang YW, Sun Y, Sun W, Lin A, Bresnahan JC, Maze M, Beattie MS, Pan JZ. Dexmedetomidine modulates neuroinflammation and improves outcome via alpha2-adrenergic receptor signaling after rat spinal cord injury. Br J Anaesth. 2019 Dec;123(6):827-838. doi: 10.1016/j.bja.2019.08.026. Epub 2019 Oct 14.
PMID: 31623841BACKGROUNDBlaise G, Roy WL. Postoperative pain relief after hypospadias repair in pediatric patients: regional analgesia versus systemic analgesics. Anesthesiology. 1986 Jul;65(1):84-6. doi: 10.1097/00000542-198607000-00016. No abstract available.
PMID: 3729064RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident
Study Record Dates
First Submitted
January 4, 2022
First Posted
January 18, 2022
Study Start
January 1, 2022
Primary Completion
July 1, 2023
Study Completion
November 1, 2023
Last Updated
January 18, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share