Phase 4
N=63
Effect of Ketorolac on Post Adenotonsillectomy Pain
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT03467750 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Post-Anesthesia Care Unit (PACU) Morphine Requirements — 0.033; 0.058 mg/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketorolac (Drug); Standard of Care (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-Anesthesia Care Unit (PACU) Morphine Requirements |
0.033; 0.058 | — |
| SECONDARY Face, Legs, Activity, Cry, Consolability (FLACC) Scale Score |
1.74; 2.87; 2.37; 3.23; 0.85; 0.77 | — |
| SECONDARY Post-Anesthesia Care Unit (PACU) Recovery Time |
63.4; 49.7 | — |
| SECONDARY Number of Participants With Post-Tonsillectomy Bleeding |
1; 2 | — |
| SECONDARY Pain Medication Administration |
0.017; 0.040 | — |
Summary
This randomized prospective study aims to determine the effect of ketorolac on the total dose of morphine required to achieve postoperative analgesia in children with obstructive sleep apnea (OSA) undergoing adenotonsillectomy. Participants will be randomly assigned to a study group where they will receive ketorolac in addition to the standard of care treatment or will receive only the standard of care pain management. The researchers hypothesize that by administering ketorolac at the end of the procedure once hemostasis has been achieved, it will be possible to decrease the amount of morphine administered in the post-anesthesia care unit (PACU). This study aims to provide a more comprehensive understanding of the efficacy and safety of the current standard post-operative analgesic regimen employed at the study institution, in which opioid analgesia currently plays a prominent role.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of sleep disordered breathing or obstructive sleep apnea
- Children undergoing elective tonsillectomy or adenotonsillectomy at Children's Healthcare of Atlanta Egleston location
- Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent
Exclusion Criteria
- Known coagulation defect
- Patients on longstanding NSAID therapy
- Known renal impairment
Data sourced from ClinicalTrials.gov (NCT03467750). 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.