Intravenous Dexmedetomidin on Postoperative Pain After Hypospadias Repair in Children
Primary Purpose
Postoperative Pain
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring dexmedetomidine, ketorolac
Eligibility Criteria
Inclusion Criteria:
- ASA physical status I & II.
- Age between 2 years & 6 years old.
- Body weight below 30 Kg.
Exclusion Criteria:
- Any contraindications to any drug used
- patients refusal
- recurrent surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group 1
group 2
Arm Description
ketorolac group: number = 30 patients , time : after intubation, dose 0.9 mg/kg
Dexmedetomidine group: number : 30 patients, time : after intubation, dose 1 μg/kg
Outcomes
Primary Outcome Measures
Total analgesic consumption in the first 24 hours after surgery
Total analgesic consumption in the first 24 hours after surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05194904
Brief Title
Intravenous Dexmedetomidin on Postoperative Pain After Hypospadias Repair in Children
Official Title
Intrtavenous Ketorolac Versus Intravenous Dexmedetomidine for Postoperative Analgesia After Hypospadius Repair
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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
Detailed Description
The guidelines of the American Society of Anesthesiologists (ASA) for the treatment of pain in the perioperative period define postoperative acute pain as pain present in surgical patients following the procedure.1 Almost 80% of patients undergoing surgery experience postoperative pain, and 80% of them reported moderate to severe pain intensity.2 Inadequate management of postoperative pain may lead to development of complications and prolonged recovery time with increased morbidity and mortality rates in adults.3,4 Although equivalent data for children are not available, this evidence warrants caution in pediatric population too. Appropriate treatment of postoperative pain contributes to shorter time of hospitalization, lower hospital costs, and increased level of patient satisfaction. There is enough evidence that an ineffective treatment of postoperative pain is in positive correlation with delayed wound healing, and the negative development of pain perception and chronic pain in the future.5,6 Hypospadias repair surgery is an invasive procedure whose postoperative phase is very painful.7 Pain management can be counted as an important step in all surgeries, especially in pediatric and neonatal surgical procedures. It has been reported that up to 40% of the children undergoing surgeries suffer from moderate to severe post-operative pain.8 In addition to the significance of post-operative pain management in the quality of life and satisfaction of the patients, it plays a great role in minimizing the complications and improving the surgery outcome in certain types of surgeries. In hypospadias surgery, post-operative pain results in manipulation of wounds and consequent infection, hemorrhage, and wound dehiscence.9 These complications cause significant preventable morbidities. Post-operative pain management also alleviates the local and systemic inflammation resulting in more favorable outcomes.10
Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that has an analgesic efficacy similar to commonly used opioids, and that recently has found wide acceptance in the treatment of postoperative pain in a variety of surgical procedures. Ketorolac is used for moderate pain relief; it may be used to treat severe pain when associated with opioids, reducing the opioid dose. The advantage of this association is the reduction of opioid side effects such as respiratory depression, pruritus, urinary retention, sedation and nausea . 11,12,13 Dexmedetomidine is a highly selective α2-adrenergic receptor agonist commonly used in neurosurgery . The advantages of dexmedetomidine include reducing perioperative catecholamine to maintain intraoperative hemodynamic stability and exerting the unique neuroprotective effects by inhibiting the release of glutamate, pro-apoptotic proteins, and pro-inflammatory cytokines. In addition, previous studies have shown that it can reduce sedative and opioid consumption and provide better analgesic effects with lesser concern for side effects than opioids
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
dexmedetomidine, ketorolac
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Active Comparator
Arm Description
ketorolac group: number = 30 patients , time : after intubation, dose 0.9 mg/kg
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
Dexmedetomidine group: number : 30 patients, time : after intubation, dose 1 μg/kg
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
ketorolac
Intervention Description
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
Primary Outcome Measure Information:
Title
Total analgesic consumption in the first 24 hours after surgery
Description
Total analgesic consumption in the first 24 hours after surgery
Time Frame
first 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA physical status I & II.
Age between 2 years & 6 years old.
Body weight below 30 Kg.
Exclusion Criteria:
Any contraindications to any drug used
patients refusal
recurrent surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammed Samir Ghitany, master
Phone
+201096594245
Email
muhammadsamir248@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled Abdel-Baki Abdel-Rahman, prof
Phone
+201008182061
Email
khaledbaky@aun.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31623841
Citation
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.
Results Reference
background
PubMed Identifier
3729064
Citation
Blaise 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.
Results Reference
result
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Intravenous Dexmedetomidin on Postoperative Pain After Hypospadias Repair in Children
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