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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-18
SponsorBaylor Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age group: 3 years to 18 years

General surgery service (hernia, appendectomy, chole, circumcision, wounds, vacs, implanted central line, etc.)

Disqualifiers

Patients who are allergic to acetaminophen and/or ibuprofen

Patients being evaluated by SANE or evaluated for nonaccidental trauma

Patients admitted post-op

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acetaminophen

    Drug

    administered alternatively with other drug

  • Ibuprofen

    Drug

    administered alternatively with other drug

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 2 interventions
Group B: Group BActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
24, 48, and 72 hours after surgery
2

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.

Time frame
24, 48, and 72 hours after surgery
3

Numeric Pain Rating Scale (NPRS)

The NPRS is scored on an 11-point scale where the higher the number indicating severe more the pain.

Time frame
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.

Time frame
72 hours after surgery

Other outcomes

Sponsors and contacts

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Baylor Research Institute

Lead sponsor

Baylor Scott and White Health

Collaborator

This trial is not recruiting at the moment. You can still explore other options: