Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Tonsillectomy

Treatments: Drug: Intravenous ibuprofen; Other: Normal Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01332253

CPI-CL-014

Details and patient eligibility

About

The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.

Enrollment: 161 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients between 6 and 17 years of age scheduled to undergo tonsillectomy.

Exclusion criteria

1. Have inadequate intravenous access
2. Patients with significant cognitive impairment
3. Active, clinically significant asthma
4. History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), cyclooxygenase-2 inhibitors, or fentanyl.
5. Have a history of congenital bleeding diathesis (e.g. hemophilia) or any active clinically significant bleeding
6. Any child with obstructive sleep apnea, defined as an Apnea-Hypopnea Index of greater than or equal to 5.0
7. Have taken investigational drugs within 30 days before clinical trial material administration.
8. Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions. Surrogates will be needed for most patients.
9. Refusal to provide written authorization for use and disclosure of protected health information.
10. Be otherwise unsuitable for the study, in the opinion of the Investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

161 participants in 2 patient groups, including a placebo group

Intravenous Ibuprofen

Experimental group

Treatment:

Drug: Intravenous ibuprofen

Normal Saline

Placebo Comparator group

Treatment:

Other: Normal Saline