Effect of Ketorolac on Post Adenotonsillectomy Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 2 - 18 |
| Updated: | 7/27/2018 |
| Start Date: | July 19, 2018 |
| End Date: | August 24, 2020 |
| Contact: | Eric Hoar |
| Email: | eric.hoar@choa.org |
| Phone: | 404-785-1376 |
Ketorolac as a Strategy for Reducing Post-operative Opioid Requirements in Children With Obstructive Sleep Apnea Undergoing Adenotonsillectomy: a Randomized Controlled Trial
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.
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.
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.
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.
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
We found this trial at
1
site
1405 Clifton Road NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
404-785-6000
Phone: 404-785-1376
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