Effect of Ketorolac on Post Adenotonsillectomy Pain
Ključne riječi
Sažetak
Opis
Obstructive sleep apnea (OSA) as an indication for adenotonsillectomy has increased significantly over the past ten years, and now has surpassed recurrent tonsillitis as the most common indication for this procedure. Opioids continue to be the most commonly administered pain medication for these procedures. Studies have shown that patients with OSA have significantly increased sensitivity to opioids that results in post-operative respiratory depression and apnea when administered via standard opioid dosing protocols. Children with OSA were shown to have a nearly fivefold increase in the odds of developing respiratory complications when compared to their counterparts with tonsillitis. Ketorolac possesses similar efficacy to morphine without the problematic complications of respiratory depression, nausea and vomiting, which are commonly seen post-adenotonsillectomy. Importantly, when combined with opioids, ketorolac is opioid-sparing. This synergistic effect means that a similar level of analgesia is achieved using a lower dose of opioid. However, there continues to be concern about using ketorolac due to the potential risk of post-operative bleeding from anti-platelet activity.
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 OSA undergoing adenotonsillectomy. Participants will be randomly assigned to receive ketorolac or to not receive ketorolac. The post-anesthesia care unit (PACU) nurses, who will be blinded to ketorolac administration, will evaluate the patients using the Face, Legs, Activity, Cry, Consolability (FLACC) scale scores at 10 minutes post-op, 20 minutes post-op and at time of PACU discharge. For patients with a FLACC score of 6-10, morphine (0.05mg/kg) will be administered. For patients with FLACC scores of 3-5, morphine (0.025mg/kg) will be administered. The total amount of opioid required to obtain a FLACC score of less than 3 will be evaluated as the primary outcome. The secondary outcomes to be evaluated will be PACU FLACC scores, time required in PACU, incidence of post-tonsillectomy bleeding and total pain medications administered during hospital admission.
Datumi
| Posljednja provjera: | 06/30/2019 |
| Prvo podneseno: | 03/11/2018 |
| Predviđena prijava poslana: | 03/11/2018 |
| Prvo objavljeno: | 03/15/2018 |
| Posljednje ažuriranje poslano: | 07/24/2019 |
| Posljednje ažuriranje objavljeno: | 07/25/2019 |
| Stvarni datum početka studija: | 07/18/2018 |
| Procijenjeni datum primarnog završetka: | 08/23/2020 |
| Procijenjeni datum završetka studije: | 08/23/2020 |
Stanje ili bolest
Intervencija / liječenje
Drug: Ketorolac
Drug: Standard of Care
Faza
Grupe ruku
| Ruka | Intervencija / liječenje |
|---|---|
| Experimental: Ketorolac Participants randomized to the ketorolac group will receive 0.5mg/kg IV at the end of the adenotonsillectomy procedure, once hemostasis has been achieved | Drug: Ketorolac Patients in this group will receive 0.5mg/kg of ketorolac, administered intravenously. |
| Active Comparator: Standard of Care Participants randomized to this group will receive the pain management standard of care for the adenotonsillectomy procedure. |
Kriterij prihvatljivosti
| Dobni uvjeti za studiranje | 2 Years Do 2 Years |
| Spolovi koji ispunjavaju uvjete za studij | All |
| Prihvaća zdrave volontere | Da |
| Kriteriji | 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 - Patients may also be excluded at the discretion of the investigator |
Ishod
Primarne mjere ishoda
1. Post-Anesthesia Care Unit (PACU) Morphine Requirements [Until PACU discharge (typically within 3 hours)]
Sekundarne mjere ishoda
1. Face, Legs, Activity, Cry, Consolability (FLACC) Scale Score [10 minutes post-op, 20 minutes post-op, PACU discharge (typically within 3 hours)]
2. Post-Anesthesia Care Unit (PACU) Recovery Time [Until PACU discharge (typically within 3 hours)]
3. Incidence of Post-Tonsillectomy Bleeding [Until complete recovery (typically within 7 days after surgery)]
4. Pain Medication Administration [Surgery through hospital discharge (typically within 2 days)]
