Postoperative Pain, AcutePhase 2NCT06267820
Combined Ketorolac Bupivacaine Versus Bupivacaine Alone for TAP Block in Children Undergoing Lower Abdominal Surgeries
A Phase 2 study testing Bupivacain and Ketorolac in people with Postoperative Pain, Acute, run by Sohag University at 1 site in Egypt.
Trial summary
Control of of pain in children is fundamental. TAP block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance. Ketorolac has analgesic effect comparable to morphine. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Bupivacain and Ketorolac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 10 Dec 2023
- Phase
- Phase 2
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA status I and II children Age 6-12 years Elective lower abdominal surgeries.
Who cannot join
- Parents' or legal guardians' refusal.
- A history of developmental delay or mental retardation.
- ASA III and IV.
- A known allergy to ketorolac or bupivacaine.
- Hemodynamic unstable patient
- Urgent surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Combined Ketorolac Bupivacaine and Bupivacaine Alone for Transversus Abdominis Plane Block in Children Undergoing Lower Abdominal Surgeries: A Prospective Double- Blind Randomized Clinical Trial
Control of of pain in children is fundamental. TAP block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance.
Ketorolac has analgesic effect comparable to morphine. Children were arranged randomly into two equal groups, forty-five children in each.
Group (K) (n= 45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).
Group (T) (n =45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg)
Read the detailed description
This prospective randomized controlled study were carried out in Sohag university hospitals after getting approval from medical research ethics committee and written informed consents from the patients' parents or legal guardians. This study included 90 ASA status I and II children aged 6-12 years undergoing elective lower abdominal surgeries.Preoperative assessment:
- History taking from the parents.
- Complete physical examination.
- Laboratory investigations: Complete Blood Picture and coagulation profile. Preoperative preparation
Before starting, standard monitoring will be as follow:
- Non-invasive blood pressure (systolic and diastolic).
- Peripheral Oxygen saturation (SpO2%). After insertion of intravenous line, all children will receive atropine premedication (0.01-0.02 mg/kg). General anesthesia will be induced using propofol 1% (2 mg/kg), atracurium (0.5 mg/kg) to facilitate endotracheal intubation. Anesthesia will be maintained using isoflurane (1-2%) with controlled ventilation.At the end of operation, muscle relaxant is reversed using neostigmine and atropine.
Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery).
Then TAP block were done under ultrasound guidance using either bupivacaine and ketorolac or bupivacaine alone
- Conditions
- Postoperative Pain, Acute
- Being tested
- Bupivacain, Ketorolac
- Keywords
- TAP, ketorolac, bupivacaine,, ultrasound, children
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Also called bupivacaine
analgesia
KetorolacDrug
analgesia
| Study group | Role | What they receive |
|---|---|---|
| TAP block with bupivacaine and ketorolac | Active comparator | Ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg). Receives: Drug: Bupivacain; Drug: Ketorolac |
| TAP block with bupivacaine | Active comparator | ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg). Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
1st analgesic requirement
the time at which the 1st need for analgesia is given.
Measured: 24 hours
Number of patients who requested analgesia
Number (percentage)of patients who requested analgesia
Measured: 24 hours
Secondary outcomes (5)
heart rate
the patient vital sign (beats/min)
Measured: 24 hours
Total rescue analgesia
Total rescue analgesia in the first 24 h. postoperatively
Measured: 24 hours
Satisfaction of the parents regarding their children analgesia
using 5- point satisfaction scale (1= Very satisfied, 2=Satisfied,3= Neither satisfied nor dissatisfied,4= Dissatisfied, 5= Very dissatisfied).
This satisfaction will be done by parents according to the VAS, incidence of side effects and analgesic requirements
Measured: 24 hours
Number of children in each group who required analgesia in the first 24 h postoperatively
Number of children in each group who required analgesia in the first 24h postoperatively
Measured: 24 hours
blood pressure
The patients blood pressure (mmHg)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Jun 2023
- Primary completion1 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fouad Soliman, Sohag University
- Investigators
- Fouad I Soliman, MD, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267820
- Sponsor's protocol ID
- 2010
- Status last verified
- Jun 2024
- First submitted
- 13 Dec 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Combined Ketorolac Bupivacaine and Bupivacaine Alone for Transversus Abdominis Plane Block in Children Undergoing Lower Abdominal Surgeries: A Prospective Double- Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06267820
- Acronym / sponsor ID
- 2010
- Conditions
- Postoperative Pain, Acute
- Keywords
- TAP, ketorolac, bupivacaine,, ultrasound, children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 20 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.
Control of of pain in children is fundamental. TAP block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance.
Ketorolac has analgesic effect comparable to morphine. Children were arranged randomly into two equal groups, forty-five children in each.
Group (K) (n= 45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).
Group (T) (n =45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg)
Detailed description
This prospective randomized controlled study were carried out in Sohag university hospitals after getting approval from medical research ethics committee and written informed consents from the patients' parents or legal guardians. This study included 90 ASA status I and II children aged 6-12 years undergoing elective lower abdominal surgeries.Preoperative assessment:
- History taking from the parents.
- Complete physical examination.
- Laboratory investigations: Complete Blood Picture and coagulation profile. Preoperative preparation
Before starting, standard monitoring will be as follow:
- Non-invasive blood pressure (systolic and diastolic).
- Peripheral Oxygen saturation (SpO2%). After insertion of intravenous line, all children will receive atropine premedication (0.01-0.02 mg/kg). General anesthesia will be induced using propofol 1% (2 mg/kg), atracurium (0.5 mg/kg) to facilitate endotracheal intubation. Anesthesia will be maintained using isoflurane (1-2%) with controlled ventilation.At the end of operation, muscle relaxant is reversed using neostigmine and atropine.
Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery).
Then TAP block were done under ultrasound guidance using either bupivacaine and ketorolac or bupivacaine alone
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block with bupivacaine and ketorolac | Active comparator | Drug: Bupivacain, Drug: KetorolacUltrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg). |
| TAP block with bupivacaine | Active comparator | Drug: Bupivacainultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA status I and II children Age 6-12 years Elective lower abdominal surgeries.
Key exclusion criteria (6 listed)
- Parents' or legal guardians' refusal.
- A history of developmental delay or mental retardation.
- ASA III and IV.
- A known allergy to ketorolac or bupivacaine.
- Hemodynamic unstable patient
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 |
|---|---|---|
| BupivacainAlso: bupivacaineanalgesia | Drug | TAP block with bupivacaine, TAP block with bupivacaine and ketorolac |
| Ketorolacanalgesia | Drug | TAP block with bupivacaine and ketorolac |
Primary outcome
1st analgesic requirement
Time frame: 24 hours
the time at which the 1st need for analgesia is given.
Number of patients who requested analgesia
Time frame: 24 hours
Number (percentage)of patients who requested analgesia
5 secondary outcomes
heart rate
Time frame: 24 hours
Total rescue analgesia
Time frame: 24 hours
Satisfaction of the parents regarding their children analgesia
Time frame: 24 hours
Number of children in each group who required analgesia in the first 24 h postoperatively
Time frame: 24 hours
blood pressure
Time frame: 24 hours
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 26 Jun 2024.
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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.
Fouad I Soliman, MD principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacain and Ketorolac in people with Postoperative Pain, Acute, run by Sohag 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 1 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: finished, as of the sponsor's last update on 26 Jun 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
1st analgesic requirement (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 Jun 2024.