SurgeryPhase 1NCT05444036
Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline
A Phase 1 study testing Ketamine in people with Surgery and Pediatric Surgery, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Because pain is difficult to measure in children, post-operative pain is frequently undertreated in this age range. Pain treatment is required in children due to the high emotional component of pain. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Surgery, Pediatric Surgery
- What is being tested?
- Ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 1 Jun 2019
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1- All children whom were diagnosed with herniotomy, orchidopexy, or urethroplasty.
Who cannot join
- Drugs used allergy or sensitivity,
- contraindications to caudal injection, such as infection at the injection site,
- bleeding disorders
- caudal vertebral abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline in Pediatric Surgical Procedures Below the Umbilicus
Because pain is difficult to measure in children, post-operative pain is frequently undertreated in this age range. Pain treatment is required in children due to the high emotional component of pain. Pain is a multidimensional, subjective, perceptual event having a variety of qualities such as intensity, quality, time course, and effects that are perceived differently by each person. Because the operational definition of pain necessitates self-report, pain experienced by children and babies is frequently overlooked, if not ignored.
When general anesthesia is paired with regional procedures, children of all ages are exposed to less intravenous and inhalational anesthetics and analgesics, leaving them nearly free of nausea, vomiting, itching, or unneeded drowsiness. Being completely awake and able to drink soon after surgery, as well as having no issues breathing even after lengthy surgery, are significant benefits that children and parents value.
Read the detailed description
Caudal block provides the potential benefit of extending the length and effectiveness of the block by combining additional medications with the local anaesthetic agent. Morphine, clonidine, ketamine, and midazolam were among the drugs used.
Although peripheral nerve blocks and caudal anesthesia are relatively safe, extreme attention is required to minimize adverse consequences. Pediatric anesthesiologists must have adequate training to ensure patient safety. A well-trained pediatric anesthesiologist will try to avoid unsafe regional anesthetic application methods and will always be prepared to manage dangerous side effects (overdoses, intravenous administration induced seizures, tip displacement of epidural catheters or centrally located abscesses).
Ketamine is a non-competitive N-methyl D-aspartate NMDA receptor antagonist that is thought to prevent or reverse central sensitization and, as a result, lessen postoperative pain. It also has a peripheral analgesic effect.
Ketamine infiltration has been demonstrated to provide pain alleviation in children having adenotonsillectomy for up to 24 hours following surgery with no adverse effects.
- Conditions
- Surgery, Pediatric Surgery
- Being tested
- Ketamine
- Keywords
- Caudal bupivacaine, ketamine, anaesthesia, paediatric surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
compare caudal ketamine-bupivacaine against caudal bupivacaine-saline in paediatric Measuring pain in patients undergoing surgery below the umbilicus with regard to analgesic, anaesthetic, and sedative properties
| Study group | Role | What they receive |
|---|---|---|
| Ketamin-bupivacaine Group | Experimental | in this method,30 patients which received 0.5 mg/kg of preservative free ketamine (i.e. 0.05ml/kg of 10mg/ml ketamine diluted up to 1ml in normal saline) plus1ml/kg of 0.25 % bupivacaine caudally, after induction of general anaesthesia Receives: Drug: Ketamine |
| bupivacaine-saline Group | Experimental | 30 patients received 1ml/kg of 0.25 % bupivacaine plus 1ml of normal saline caudally of just after induction of general anaesthesia, just after induction of general anaesthesia Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Post-operative Pain
Assessment of the pain post-operatively in Pediatric patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain, measured in millimetres from the left end bar to the mark placed by the kid on the 10 cm line anchored by happy faces (no pain) to sad faces (severe pain).
Measured: 24-hour analgesic after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Sep 2018
- Primary completion15 May 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparing caudal block by bupivacaine with and without ketamine in paediatric patients undergoing surgery below the umbilicus with regard to analgesic, anaesthetic, and sedative properties.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nirvana Elshalakany, Professor, Principal investigator, Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444036
- Sponsor's protocol ID
- NIRVANA 2
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline in Pediatric Surgical Procedures Below the Umbilicus
- ClinicalTrials.gov ID
- NCT05444036
- Acronym / sponsor ID
- NIRVANA 2
- Conditions
- Surgery, Pediatric Surgery
- Keywords
- Caudal bupivacaine, ketamine, anaesthesia, paediatric surgeries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 5 Jul 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.
Because pain is difficult to measure in children, post-operative pain is frequently undertreated in this age range. Pain treatment is required in children due to the high emotional component of pain. Pain is a multidimensional, subjective, perceptual event having a variety of qualities such as intensity, quality, time course, and effects that are perceived differently by each person. Because the operational definition of pain necessitates self-report, pain experienced by children and babies is frequently overlooked, if not ignored.
When general anesthesia is paired with regional procedures, children of all ages are exposed to less intravenous and inhalational anesthetics and analgesics, leaving them nearly free of nausea, vomiting, itching, or unneeded drowsiness. Being completely awake and able to drink soon after surgery, as well as having no issues breathing even after lengthy surgery, are significant benefits that children and parents value.
Detailed description
Caudal block provides the potential benefit of extending the length and effectiveness of the block by combining additional medications with the local anaesthetic agent. Morphine, clonidine, ketamine, and midazolam were among the drugs used.
Although peripheral nerve blocks and caudal anesthesia are relatively safe, extreme attention is required to minimize adverse consequences. Pediatric anesthesiologists must have adequate training to ensure patient safety. A well-trained pediatric anesthesiologist will try to avoid unsafe regional anesthetic application methods and will always be prepared to manage dangerous side effects (overdoses, intravenous administration induced seizures, tip displacement of epidural catheters or centrally located abscesses).
Ketamine is a non-competitive N-methyl D-aspartate NMDA receptor antagonist that is thought to prevent or reverse central sensitization and, as a result, lessen postoperative pain. It also has a peripheral analgesic effect.
Ketamine infiltration has been demonstrated to provide pain alleviation in children having adenotonsillectomy for up to 24 hours following surgery with no adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- comparing caudal block by bupivacaine with and without ketamine in paediatric patients undergoing surgery below the umbilicus with regard to analgesic, anaesthetic, and sedative properties.
| Arm | Type | Receives |
|---|---|---|
| Ketamin-bupivacaine Group | Experimental | Drug: Ketaminein this method,30 patients which received 0.5 mg/kg of preservative free ketamine (i.e. 0.05ml/kg of 10mg/ml ketamine diluted up to 1ml in normal saline) plus1ml/kg of 0.25 % bupivacaine caudally, after induction of general anaesthesia |
| bupivacaine-saline Group | Experimental | Drug: Ketamine30 patients received 1ml/kg of 0.25 % bupivacaine plus 1ml of normal saline caudally of just after induction of general anaesthesia, just after induction of general anaesthesia |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1- All children whom were diagnosed with herniotomy, orchidopexy, or urethroplasty.
Key exclusion criteria (4 listed)
- Drugs used allergy or sensitivity,
- contraindications to caudal injection, such as infection at the injection site,
- bleeding disorders
- caudal vertebral abnormalities
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 |
|---|---|---|
| Ketaminecompare caudal ketamine-bupivacaine against caudal bupivacaine-saline in paediatric Measuring pain in patients undergoing surgery below the umbilicus with regard to analgesic, anaesthetic, and sedative properties | Drug | Ketamin-bupivacaine Group, bupivacaine-saline Group |
Primary outcome
Measurement of Post-operative Pain
Time frame: 24-hour analgesic after surgery
Assessment of the pain post-operatively in Pediatric patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain, measured in millimetres from the left end bar to the mark placed by the kid on the 10 cm line anchored by happy faces (no pain) to sad faces (severe pain).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 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.
Nirvana Elshalakany, Professor principal investigator
Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine in people with Surgery and Pediatric Surgery, run by Egymedicalpedia 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 10 Sep 2022. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Post-operative Pain (time frame: 24-hour analgesic after surgery). 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 10 Sep 2022.