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

Baylor Scott and White Health (BSWH)

Status and phase

Not yet enrolling

Phase 4

Conditions

Pediatric Disorder

Treatments

Drug: Ibuprofen

Drug: Acetaminophen

Study type

Interventional

Funder types

Other

Identifiers

NCT06505148

024-301

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

3 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Drug: Acetaminophen

Drug: Ibuprofen

Group B

Active Comparator group

Description:

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

Treatment:

Drug: Acetaminophen

Drug: Ibuprofen