Pediatric DisorderPhase 4NCT06505148
Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?
A Phase 4 study testing Acetaminophen and Ibuprofen in people with Pediatric Disorder, run by Baylor Research Institute at 1 site in United States.
Trial summary
To examine the difference in pain control in the pediatric general surgery population alternating acetaminophen and Ibuprofen q 3 hours vs giving them simultaneous combination therapy around the clock. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Pediatric Disorder
- What is being tested?
- Acetaminophen and Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 1 Aug 2025
- Phase
- Phase 4
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age group: 3 years to 18 years
- General surgery service (hernia, appendectomy, chole, circumcision, wounds, vacs, implanted central line, etc.)
Who cannot join
- Patients who are allergic to acetaminophen and/or ibuprofen
- Patients being evaluated by SANE or evaluated for nonaccidental trauma
- Patients admitted post-op
- The study will take place at McLane Children's Hospital Temple Market. Patients who are pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baylor Scott & White Health Temple Market
Temple, Texas, 76508
Marlene T Porter, PhD, 254-724-9069, marlene.porter@bswhealth.org
About this study
To examine the difference in pain control in the pediatric general surgery population alternating acetaminophen and Ibuprofen q 3 hours vs giving them simultaneous combination therapy around the clock.
Read the detailed description
The purpose of the study is to compare the difference in pain control in the pediatric general surgery population of those who receive alternating acetaminophen and ibuprofen every 3 hours to those who receive acetaminophen and ibuprofen combined therapy around the clock. Additionally, to investigate the difference in parent adherence to pain treatment plans between the alternating group from the combined group.
- Conditions
- Pediatric Disorder
- Being tested
- Acetaminophen, Ibuprofen
- Keywords
- non opioid, pain management, pediatric pain, pediatric pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
administered alternatively with other drug
IbuprofenDrug
administered alternatively with other drug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will prescribe study participants in group 1 acetaminophen and ibuprofen alternating treatment every three hours. The dosage will be weight-based. Receives: Drug: Acetaminophen; Drug: Ibuprofen |
| Group B | Active comparator | Group B will be prescribed acetaminophen and ibuprofen combined treatment every 6 hours. The dosage will be weight-based. Receives: Drug: Acetaminophen; Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale.
Pain will be assessed using an age-appropriate pain rating scale. The FLACC is an interval scale quantifying pain behavior with scores ranging from 0 no pain behaviors to 10 most possible pain behaviors. The five categories of behaviors assessed with the FLAC include facial expressions, leg movement, activity, crying, and consolability.
Measured: 24, 48, and 72 hours after surgery
Pain Visual Analog Scale (VAS)
This tool portrays a 10cm ruler visual and the patient selects the marker indicating their pain intensity, 0 indicating no pain to 10 indicating the worst pain possible.
Measured: 24, 48, and 72 hours after surgery
Numeric Pain Rating Scale (NPRS)
The NPRS is scored on an 11-point scale where the higher the number indicating severe more the pain.
Measured: 24, 48, and 72 hours after surgery
Secondary outcomes (1)
Parent/ guardian adherence
Adherence will be assessed by asking the parent/guardian regarding their ability to follow pain regimen and the ease to follow the instructions.
Measured: 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will be prescribed the acetaminophen and ibuprofen alternating every 3 hours. And the other group will be prescribed acetaminophen and ibuprofen combine treatment.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor Scott and White Health
- Responsible party
- Principal investigator, Marlene Porter, Baylor Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505148
- Sponsor's protocol ID
- 024-301
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data-sharing considerations will be addressed upon receipt of a formal request. Upon receipt of a formal request, data sharing will proceed once a data-sharing agreement has been established. The rationale for the data sharing plan is that data obtained for the study is considered proprietary to BSWH.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?
- ClinicalTrials.gov ID
- NCT06505148
- Acronym / sponsor ID
- 024-301
- Conditions
- Pediatric Disorder
- Keywords
- non opioid, pain management, pediatric pain, pediatric pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Baylor Scott and White Health
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 17 Jul 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.
To examine the difference in pain control in the pediatric general surgery population alternating acetaminophen and Ibuprofen q 3 hours vs giving them simultaneous combination therapy around the clock.
Detailed description
The purpose of the study is to compare the difference in pain control in the pediatric general surgery population of those who receive alternating acetaminophen and ibuprofen every 3 hours to those who receive acetaminophen and ibuprofen combined therapy around the clock. Additionally, to investigate the difference in parent adherence to pain treatment plans between the alternating group from the combined group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group will be prescribed the acetaminophen and ibuprofen alternating every 3 hours. And the other group will be prescribed acetaminophen and ibuprofen combine treatment.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Acetaminophen, Drug: IbuprofenGroup A will prescribe study participants in group 1 acetaminophen and ibuprofen alternating treatment every three hours. The dosage will be weight-based. |
| Group B | Active comparator | Drug: Acetaminophen, Drug: IbuprofenGroup B will be prescribed acetaminophen and ibuprofen combined treatment every 6 hours. The dosage will be weight-based. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age group: 3 years to 18 years
- General surgery service (hernia, appendectomy, chole, circumcision, wounds, vacs, implanted central line, etc.)
Key exclusion criteria (4 listed)
- Patients who are allergic to acetaminophen and/or ibuprofen
- Patients being evaluated by SANE or evaluated for nonaccidental trauma
- Patients admitted post-op
- The study will take place at McLane Children's Hospital Temple Market. Patients who are pregnant.
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 |
|---|---|---|
| Acetaminophenadministered alternatively with other drug | Drug | Group A, Group B |
| Ibuprofenadministered alternatively with other drug | Drug | Group A, Group B |
Primary outcome
Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale.
Time frame: 24, 48, and 72 hours after surgery
Pain will be assessed using an age-appropriate pain rating scale. The FLACC is an interval scale quantifying pain behavior with scores ranging from 0 no pain behaviors to 10 most possible pain behaviors. The five categories of behaviors assessed with the FLAC include facial expressions, leg movement, activity, crying, and consolability.
Pain Visual Analog Scale (VAS)
Time frame: 24, 48, and 72 hours after surgery
This tool portrays a 10cm ruler visual and the patient selects the marker indicating their pain intensity, 0 indicating no pain to 10 indicating the worst pain possible.
Numeric Pain Rating Scale (NPRS)
Time frame: 24, 48, and 72 hours after surgery
The NPRS is scored on an 11-point scale where the higher the number indicating severe more the pain.
1 secondary outcome
Parent/ guardian adherence
Time frame: 72 hours after surgery
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 22 Jul 2024.
- Individual participant dataSharing planned: No. Data-sharing considerations will be addressed upon receipt of a formal request. Upon receipt of a formal request, data sharing will proceed once a data-sharing agreement has been established. The rationale for the data sharing plan is that data obtained for the study is considered proprietary to BSWH.
Related trials for Pediatric Disorder
RecruitingPhase 1
Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)
Ewing Sarcoma
Not yet recruitingEarly Phase 1
SPX-01 Gene Therapy in Pediatric Patients With Spinal Muscular Atrophy Type 1 (RISE)
Spinal Muscular Atrophy (SMA)
RecruitingObservational study
Long-Term Follow-Up of Survivors of Pediatric Cushing Disease
Cushing Disease
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
Enrolling by invitation
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Heart Failure, Transplant; Failure, Heart
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.
Baylor Scott & White Health Temple Market
Temple, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen and Ibuprofen in people with Pediatric Disorder, run by Baylor Research Institute at 1 site in United States.
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 2 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: opening soon, as of the sponsor's last update on 22 Jul 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale. (time frame: 24, 48, and 72 hours after surgery). The study lists 3 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 22 Jul 2024.