Postoperative PainPhase 2/3NCT05194904
Intravenous Dexmedetomidin on Postoperative Pain After Hypospadias Repair in Children
A Phase 2/3 study testing Dexmedetomidine in people with Postoperative Pain, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 year to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Nov 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA physical status I \& II.
- Age between 2 years \& 6 years old.
- Body weight below 30 Kg.
Who cannot join
- Any contraindications to any drug used
- patients refusal
- recurrent surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intrtavenous Ketorolac Versus Intravenous Dexmedetomidine for Postoperative Analgesia After Hypospadius Repair
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
Read the 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
- Conditions
- Postoperative Pain
- Being tested
- Dexmedetomidine
- Keywords
- dexmedetomidine, ketorolac
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called ketorolac
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
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | ketorolac group: number = 30 patients , time : after intubation, dose 0.9 mg/kg Receives: Drug: Dexmedetomidine |
| group 2 | Active comparator | Dexmedetomidine group: number : 30 patients, time : after intubation, dose 1 μg/kg Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total analgesic consumption in the first 24 hours after surgery
Total analgesic consumption in the first 24 hours after surgery
Measured: first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Samir Ghitany, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194904
- Sponsor's protocol ID
- intravenous dexmedetomidin
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31623841Blaise 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.
PubMed 3729064
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrtavenous Ketorolac Versus Intravenous Dexmedetomidine for Postoperative Analgesia After Hypospadius Repair
- ClinicalTrials.gov ID
- NCT05194904
- Acronym / sponsor ID
- intravenous dexmedetomidin
- Conditions
- Postoperative Pain
- Keywords
- dexmedetomidine, ketorolac
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Drug: Dexmedetomidineketorolac group: number = 30 patients , time : after intubation, dose 0.9 mg/kg |
| group 2 | Active comparator | Drug: DexmedetomidineDexmedetomidine group: number : 30 patients, time : after intubation, dose 1 μg/kg |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA physical status I \& II.
- Age between 2 years \& 6 years old.
- Body weight below 30 Kg.
Key exclusion criteria (3 listed)
- Any contraindications to any drug used
- patients refusal
- recurrent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: ketorolacThis 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 | Drug | group 1, group 2 |
Primary outcome
Total analgesic consumption in the first 24 hours after surgery
Time frame: first 24 hours
Total analgesic consumption in the first 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Background: PubMed 31623841Gao 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 publication: PubMed 3729064Blaise 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine in people with Postoperative Pain, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammed Samir Ghitany, master (+201096594245, muhammadsamir248@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total analgesic consumption in the first 24 hours after surgery (time frame: first 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05194904, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.