Postoperative PainNCT06245239
Perfusion Index in Assessment of Postoperative Pain in Children.
An observational study of Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study will be to examine the validity of perfusion index in predicting pain and evaluation of its severity in the postoperative period. Read more about this study
- Who is it for?
- Ages 1 day to 3 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- perfusion index
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 day to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged<3 years of both sexes undergoing hypospadias repair surgery.
Who may be able to join
- patients aged <3 years
- Sex:- both male and female.
- ASA I-II
- Informed written consent obtained from parents or guardians of all patients.
- Undergoing hypospadias repair surgery
Who cannot join
- Patients outside the selective age range
- Parents or guardians refusing to enroll their child in the study.
- ASA III or VI
- Children with behavioral changes or physical developmental delay
- Children treated with sedatives or anticonvulsants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Noha yahia Mohammed
Asyut, Assuit Governorate, 71515
Noha yahia Mohammed, MD, 01001890194, noha.hgagy@gmail.com
About this study
Official title: Using Perfusion Index in Assessment of Postoperative Pain in Children Undergoing Hypospadias Repair Surgery: an Observational Follow up Study.
The aim of this study will be to examine the validity of perfusion index in predicting pain and evaluation of its severity in the postoperative period.
Read the detailed description
- Hypospadias repair is a common surgery that is accompanied with significant postoperative pain. The largest group of children usually undergo this type of surgery are infants and pre-verbal children who cannot verbally report pain, and their treatment depends typically on behavioral and observational tools. Although these tools are valid and reliable measures in assessment of pediatric pain, they are still hindered by their subjectivity, which consequently could result in inadequate pain treatment that in early childhood may lead to negative behavioral and neurophysiological sequalae.
That is why recent studies have focused on developing more objective measures to evaluate pain especially when self-report is not possible.
- Changes in perfusion index(PI) caused by sympathetic stimulation refers to possible correlation between pain and PI which forms the basis of our study proposing that the PI is a non-invasive easy method that can be used in evaluating pain in infants
- Conditions
- Postoperative Pain
- Being tested
- perfusion index
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perfusion indexDevice
Also called PI
measurement of perfusion index
| Study group | Role | What they receive |
|---|---|---|
| group I | children aged < 3years undergoing hypospadias repair surgery. Receives: Device: perfusion index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of the validity of Perfusion index in predicting Postoperative pain assessed by FLACC score
The FLACC score along with the corresponding Perfusion index readings
Measured: The baseline preoperative Perfusion index., The FLACC score along with the corresponding Perfusion index readings, will be recorded postoperatively: upon arrival to the PACU and every 30 minutes for 2 hours, then at 6, 12, 18, 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Jun 2024
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Yahia Mohammd El-hagagy, Assiut University
- Investigators
- Noha yahia Mohammed, MD, Principal investigator, lecturer of anesthesia, faculty of medicine, Assiut university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245239
- Sponsor's protocol ID
- AIP0294591
- Status last verified
- Aug 2025
- First submitted
- 23 Jan 2024
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Perfusion Index in Assessment of Postoperative Pain in Children Undergoing Hypospadias Repair Surgery: an Observational Follow up Study.
- ClinicalTrials.gov ID
- NCT06245239
- Acronym / sponsor ID
- AIP0294591
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 7 Feb 2024 (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.
The aim of this study will be to examine the validity of perfusion index in predicting pain and evaluation of its severity in the postoperative period.
Detailed description
- Hypospadias repair is a common surgery that is accompanied with significant postoperative pain. The largest group of children usually undergo this type of surgery are infants and pre-verbal children who cannot verbally report pain, and their treatment depends typically on behavioral and observational tools. Although these tools are valid and reliable measures in assessment of pediatric pain, they are still hindered by their subjectivity, which consequently could result in inadequate pain treatment that in early childhood may lead to negative behavioral and neurophysiological sequalae.
That is why recent studies have focused on developing more objective measures to evaluate pain especially when self-report is not possible.
- Changes in perfusion index(PI) caused by sympathetic stimulation refers to possible correlation between pain and PI which forms the basis of our study proposing that the PI is a non-invasive easy method that can be used in evaluating pain in infants
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group I | – | Device: perfusion indexchildren aged < 3years undergoing hypospadias repair surgery. |
Who may qualify
- Ages
- 1 day to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged<3 years of both sexes undergoing hypospadias repair surgery.
Key inclusion criteria (5 listed)
- patients aged <3 years
- Sex:- both male and female.
- ASA I-II
- Informed written consent obtained from parents or guardians of all patients.
- Undergoing hypospadias repair surgery
Key exclusion criteria (5 listed)
- Patients outside the selective age range
- Parents or guardians refusing to enroll their child in the study.
- ASA III or VI
- Children with behavioral changes or physical developmental delay
- Children treated with sedatives or anticonvulsants.
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 |
|---|---|---|
| perfusion indexAlso: PImeasurement of perfusion index | Device | group I |
Primary outcome
Detection of the validity of Perfusion index in predicting Postoperative pain assessed by FLACC score
Time frame: The baseline preoperative Perfusion index., The FLACC score along with the corresponding Perfusion index readings, will be recorded postoperatively: upon arrival to the PACU and every 30 minutes for 2 hours, then at 6, 12, 18, 24 hours.
The FLACC score along with the corresponding Perfusion index readings
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- 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.
Noha yahia Mohammed, MD principal investigator
lecturer of anesthesia, faculty of medicine, Assiut university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Assiut University at 1 site in Egypt.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha yahia Mohammed, MD (01001890194, noha.hgagy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of the validity of Perfusion index in predicting Postoperative pain assessed by FLACC score (time frame: The baseline preoperative Perfusion index., The FLACC score along with the corresponding Perfusion index readings, will be recorded postoperatively: upon arrival to the PACU and every 30 minutes for 2 hours, then at 6, 12, 18, 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2025.