Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?

NCT ID: NCT06505148

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-08-01

Brief Summary

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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

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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

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Pediatric Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Group A will prescribe study participants in group 1 acetaminophen and ibuprofen alternating treatment every three hours. The dosage will be weight-based.

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

administered alternatively with other drug

Ibuprofen

Intervention Type DRUG

administered alternatively with other drug

Group B

Group B will be prescribed acetaminophen and ibuprofen combined treatment every 6 hours. The dosage will be weight-based.

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

administered alternatively with other drug

Ibuprofen

Intervention Type DRUG

administered alternatively with other drug

Interventions

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Acetaminophen

administered alternatively with other drug

Intervention Type DRUG

Ibuprofen

administered alternatively with other drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age group: 3 years to 18 years
* General surgery service (hernia, appendectomy, chole, circumcision, wounds, vacs, implanted central line, etc.)

Exclusion Criteria

* 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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor Scott and White Health

OTHER

Sponsor Role collaborator

Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Marlene Porter

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Baylor Scott & White Health Temple Market

Temple, Texas, United States

Site Status

Countries

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United States

Facility Contacts

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Marlene T Porter, PhD

Role: primary

254-724-9069

Other Identifiers

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024-301

Identifier Type: -

Identifier Source: org_study_id

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