AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

Muhammed Samir Ghitany, master contact

+201096594245

muhammadsamir248@gmail.com

Khaled Abdel-Baki Abdel-Rahman, prof contact

+201008182061

khaledbaky@aun.edu.eg

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

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 groups in NCT05194904
Study groupRoleWhat they receive
group 1Active comparatorketorolac group: number = 30 patients , time : after intubation, dose 0.9 mg/kg
Receives: Drug: Dexmedetomidine
group 2Active comparatorDexmedetomidine 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.

  1. 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.

  1. First posted18 Jan 2022
  2. Study startJan 2022 (estimated)
  3. Primary completionJul 2023 (estimated)
  4. Study completionNov 2023 (estimated)

Resources

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)
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 31623841
  • 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.

    PubMed 3729064

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in