Agitation, EmergencePhase 1NCT05245721
Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries
A Phase 1 study testing Nalbuphine and Bupivacain in people with Agitation, Emergence and Post Operative Pain, run by Assiut University.
Trial summary
Effect of caudal nalbuphine on postoperative emergence agitation in pediatrics undergoing infra-umbilical surgeries and pain assessment Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Agitation, Emergence, Post Operative Pain
- What is being tested?
- Nalbuphine and Bupivacain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Feb 2023
- Phase
- Phase 1
- 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 2_12 years
- Both genders
- ASA I_II
- Children undergoing infra-umbilical surgeries
Who cannot join
- Guardians refusal
- congenital anomalies at the lower spine or meringues
- Increased intracranial pressure
- Skin infection at site of injection
- Bleeding diathesis
- Known allergy to any drugs used
Trial locations and contacts
No sites are listed yet.
About this study
Effect of caudal nalbuphine on postoperative emergence agitation in pediatrics undergoing infra-umbilical surgeries and pain assessment
- Conditions
- Agitation, Emergence, Post Operative Pain
- Being tested
- Nalbuphine, Bupivacain
- Medical subject headings
- Emergence Delirium, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
Caudal nalbuphine injection in pediatrics undergoing infra-umbilical surgeries
BupivacainDrug
Caudal bupivacaine in pediatrics undergoing infra-umbilical surgeries
| Study group | Role | What they receive |
|---|---|---|
| Nalbuphine | Active comparator | Not described Receives: Drug: Nalbuphine; Drug: Bupivacain |
| Bupivacaine | Active comparator | Not described Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of caudal nalbuphine on postoperative emergence agitation according to Pediatric Anasthesia emergence delirium (PAED)
PAED ( The pediatric anesthesia emergence delirium scale)
Measured: Up to 2 hours postoperative
Secondary outcomes (1)
Postoperative pain assessment according to Modified Children's Hospital of Eastern Ontario Pain Scale (modified CHEOPS)
Measured: For 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Agitation, EmergenceStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Adel Ebrahim Okely, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245721
- Sponsor's protocol ID
- 17101501
- Status last verified
- Feb 2022
- First submitted
- 18 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries
- ClinicalTrials.gov ID
- NCT05245721
- Acronym / sponsor ID
- 17101501
- Conditions
- Agitation, Emergence, Post Operative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 18 Feb 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.
Effect of caudal nalbuphine on postoperative emergence agitation in pediatrics undergoing infra-umbilical surgeries and pain assessment
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nalbuphine | Active comparator | Drug: Nalbuphine, Drug: Bupivacain |
| Bupivacaine | Active comparator | Drug: Bupivacain |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 2_12 years
- Both genders
- ASA I_II
- Children undergoing infra-umbilical surgeries
Key exclusion criteria (6 listed)
- Guardians refusal
- congenital anomalies at the lower spine or meringues
- Increased intracranial pressure
- Skin infection at site of injection
- Bleeding diathesis
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 |
|---|---|---|
| NalbuphineCaudal nalbuphine injection in pediatrics undergoing infra-umbilical surgeries | Drug | Nalbuphine |
| BupivacainCaudal bupivacaine in pediatrics undergoing infra-umbilical surgeries | Drug | Bupivacaine, Nalbuphine |
Primary outcome
Effect of caudal nalbuphine on postoperative emergence agitation according to Pediatric Anasthesia emergence delirium (PAED)
Time frame: Up to 2 hours postoperative
PAED ( The pediatric anesthesia emergence delirium scale)
1 secondary outcome
Postoperative pain assessment according to Modified Children's Hospital of Eastern Ontario Pain Scale (modified CHEOPS)
Time frame: For 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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 1 study testing Nalbuphine and Bupivacain in people with Agitation, Emergence and Post Operative 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 4 inclusion and 6 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 Feb 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Rehab Adel Ebrahim (01099070718, Adelrehab273@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of caudal nalbuphine on postoperative emergence agitation according to Pediatric Anasthesia emergence delirium (PAED) (time frame: Up to 2 hours postoperative). 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 18 Feb 2022.