Phase 3
Completed N=161
Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy
Source: ClinicalTrials.gov NCT01332253 ↗Enrolled (actual)
161
Serious AEs
0.6%
Results posted
Nov 2016
Primary outcomePrimary: Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge. — 1.5; 1.7 fentanyl doses
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge. |
1.5; 1.7 | — |
| SECONDARY Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure. |
51; 55 | — |
| SECONDARY Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure. |
39; 47 | — |
| SECONDARY Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure. |
29; 35 | — |
| SECONDARY Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure. |
22; 27 | — |
| SECONDARY Time to Discharge Post Procedure. |
1.9; 1.9 | — |
| SECONDARY Time to Swallow Post Procedure. |
0.5; 0.4 | — |
| SECONDARY Parent Satisfaction With Regards to Pain Management Post Procedure. |
58; 58; 11; 6; 1; 1 | — |
| SECONDARY Parent Satisfaction With Regards to Nausea Management Post Procedure. |
64; 57; 7; 5; 0; 2 | — |
| SECONDARY Parental Satisfaction With Vomiting Control in the Post-Operative Period. |
66; 59; 3; 4; 1; 2 | — |
| SECONDARY Blood Loss During Surgery |
15; 16 | — |
Eligibility Criteria
Inclusion Criteria
- Patients between 6 and 17 years of age scheduled to undergo tonsillectomy.
Exclusion Criteria
- Have inadequate intravenous access
- Patients with significant cognitive impairment
- Active, clinically significant asthma
- History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), cyclooxygenase-2 inhibitors, or fentanyl.
- Have a history of congenital bleeding diathesis (e.g. hemophilia) or any active clinically significant bleeding
- Any child with obstructive sleep apnea, defined as an Apnea-Hypopnea Index of greater than or equal to 5.0
- Have taken investigational drugs within 30 days before clinical trial material administration.
- 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.
- Refusal to provide written authorization for use and disclosure of protected health information.
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
Data sourced from ClinicalTrials.gov (NCT01332253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.