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Analgesic

Acetaminophen + Ibuprofen for Post-Surgery Pain in Children

Phase 4

Waitlist Available

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age group: 3 years to 18 years

Be younger than 65 years old

Must not have

Patients admitted post-op

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours after surgery

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial will compare giving children alternating doses of acetaminophen and ibuprofen every 3 hours for pain control after surgery with giving them a combination of both medications together all the time.

Who is the study for?

This trial is for children who have undergone general surgery and need pain management. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.

What is being tested?

The study is testing two methods of pain control: alternating doses of acetaminophen and ibuprofen every three hours versus giving both medications together continuously. The goal is to see which method provides better pain relief in children after surgery.

What are the potential side effects?

Possible side effects from acetaminophen may include liver damage with excessive use, while ibuprofen can cause stomach upset, bleeding, or kidney problems. Side effects depend on individual reactions and dosages.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 3 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was admitted to the hospital after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24, 48, and 72 hours after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24, 48, and 72 hours after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24, 48, and 72 hours after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale.

Numeric Pain Rating Scale (NPRS)

Pain Visual Analog Scale (VAS)

Secondary study objectives

Parent/ guardian adherence

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group AExperimental Treatment2 Interventions

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

Group II: Group BActive Control2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetaminophen

2017

Completed Phase 4

~2030

Ibuprofen

2013