Trial Outcomes & Findings for Effect of Ketorolac on Post Adenotonsillectomy Pain (NCT NCT03467750)

Last Updated: 2024-09-19

Results Overview

The total postoperative morphine dosage required to achieve analgesia (defined as a Face, Legs, Activity, Cry, Consolability (FLACC) Scale score of less than 3) in children with obstructive sleep apnea undergoing adenotonsillectomy was compared between study arms to examine the effect of ketorolac administration.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

63 participants

Primary outcome timeframe

Until PACU discharge (up to 261 minutes)

Results posted on

2024-09-19

Participant Flow

Participants were recruited from Children's Healthcare of Atlanta at Egleston in Atlanta, Georgia, USA. Participant enrollment began July 19, 2018 and the final study assessment occurred on August 22, 2023.

Participant milestones

Participant milestones
Measure	Ketorolac Participants randomized to the ketorolac group received 0.5mg/kg IV at the end of the adenotonsillectomy procedure, once hemostasis was achieved. Ketorolac: Patients in this group received 0.5mg/kg of ketorolac, administered intravenously. Standard of Care: All patients underwent inhalational induction with nitrous oxide and sevoflurane. After intravenous (IV) placement, 1-3mg/kg of propofol and 1mcg/kg of fentanyl were administered. After induction, 0.5mg/kg of dexamethasone and an IV infusion of 15mg/kg of acetaminophen were administered. During surgery, 0.5mcg/kg of dexmedetomidine and 0.1mg/kg ondansetron were given. A rescue dose of 0.5-1mcg/kg of IV Fentanyl was available for use at the end of the procedure. The decision to administer was left to the discretion of the attending anesthesiologist. The choice to give this was made based on variables including patient's condition and a 20% increase in the heart rate and blood pressure. The PACU nurses, who were blinded to ketorolac administration, evaluated the patients using FLACC scores. For patients with a FLACC score of 6-10, morphine 0.05mg/kg was administered. For patients with FLACC scores of 3-5, morphine 0.025mg/kg was administered.	Standard of Care Participants randomized to this group received the pain management standard of care for the adenotonsillectomy procedure. Standard of Care: All patients underwent inhalational induction with nitrous oxide and sevoflurane. After intravenous (IV) placement, 1-3mg/kg of propofol and 1mcg/kg of fentanyl were administered. After induction, 0.5mg/kg of dexamethasone and an IV infusion of 15mg/kg of acetaminophen were administered. During surgery, 0.5mcg/kg of dexmedetomidine and 0.1mg/kg ondansetron were given. A rescue dose of 0.5-1mcg/kg of IV Fentanyl was available for use at the end of the procedure. The decision to administer was left to the discretion of the attending anesthesiologist. The choice to give this was made based on variables including patient's condition and a 20% increase in the heart rate and blood pressure. The PACU nurses, who were blinded to ketorolac administration, evaluated the patients using FLACC scores. For patients with a FLACC score of 6-10, morphine 0.05mg/kg was administered. For patients with FLACC scores of 3-5, morphine 0.025mg/kg was administered.
Overall Study STARTED	30	33
Overall Study COMPLETED	28	31
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketorolac Participants randomized to the ketorolac group received 0.5mg/kg IV at the end of the adenotonsillectomy procedure, once hemostasis was achieved. Ketorolac: Patients in this group received 0.5mg/kg of ketorolac, administered intravenously. Standard of Care: All patients underwent inhalational induction with nitrous oxide and sevoflurane. After intravenous (IV) placement, 1-3mg/kg of propofol and 1mcg/kg of fentanyl were administered. After induction, 0.5mg/kg of dexamethasone and an IV infusion of 15mg/kg of acetaminophen were administered. During surgery, 0.5mcg/kg of dexmedetomidine and 0.1mg/kg ondansetron were given. A rescue dose of 0.5-1mcg/kg of IV Fentanyl was available for use at the end of the procedure. The decision to administer was left to the discretion of the attending anesthesiologist. The choice to give this was made based on variables including patient's condition and a 20% increase in the heart rate and blood pressure. The PACU nurses, who were blinded to ketorolac administration, evaluated the patients using FLACC scores. For patients with a FLACC score of 6-10, morphine 0.05mg/kg was administered. For patients with FLACC scores of 3-5, morphine 0.025mg/kg was administered.	Standard of Care Participants randomized to this group received the pain management standard of care for the adenotonsillectomy procedure. Standard of Care: All patients underwent inhalational induction with nitrous oxide and sevoflurane. After intravenous (IV) placement, 1-3mg/kg of propofol and 1mcg/kg of fentanyl were administered. After induction, 0.5mg/kg of dexamethasone and an IV infusion of 15mg/kg of acetaminophen were administered. During surgery, 0.5mcg/kg of dexmedetomidine and 0.1mg/kg ondansetron were given. A rescue dose of 0.5-1mcg/kg of IV Fentanyl was available for use at the end of the procedure. The decision to administer was left to the discretion of the attending anesthesiologist. The choice to give this was made based on variables including patient's condition and a 20% increase in the heart rate and blood pressure. The PACU nurses, who were blinded to ketorolac administration, evaluated the patients using FLACC scores. For patients with a FLACC score of 6-10, morphine 0.05mg/kg was administered. For patients with FLACC scores of 3-5, morphine 0.025mg/kg was administered.
Overall Study Surgery canceled	1	0
Overall Study Protocol Violation	1	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Effect of Ketorolac on Post Adenotonsillectomy Pain