NCT05610384

Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy

Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the analgesic effect of intravenous ibuprofen to ketorolac for pain control after open hysterectomy

Detailed description

Thirty minutes before the surgery, all patients will receive 1 gm paracetamol intravenously then every 6 hours postoperatively. A research assistant is responsible for opening the envelopes, group assignment and drug preparation (the three doses will be prepared and marked with the patient's name as well as the time of administration) without any further involvement in the study. The patient, attending anesthetist, nurse and data collector will be blinded to the administered drug. Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 8 mg dexamethasone drugs. Anesthesia Anesthesia will be induced with 2 mg/kg propofol, 1 mcg/kg fentanyl, and tracheal intubation will be facilitated by 0.5 mg/kg atracurium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg atracurium every 20 minutes. Intraoperative analgesia will be in the form of 1 mcg/kg fentanyl boluses as needed. Postoperatively, pain assessments using the visual analogue scale (VAS) will be performed at rest and during movement (knee flexion) at 0.5, 2, 4, 6, 10, 18, and 24 h after leaving the operating room. If the VAS score is \> 3 intravenous titration of 2 mg morphine given slowly to be repeated after 30 minutes if pain persisted. Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting

Conditions

• Postoperative Pain
• Hysterectomy

Interventions

Type	Name	Description
DRUG	Ketorolac Injectable Solution	ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes before induction of anesthesia then every 8 hours postoperatively
DRUG	Ibuprofen 800 mg	ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes before induction of anesthesia then every 8 hours postoperatively.

Timeline

• Start date: 2022-11-20
• Primary completion: 2023-05-15
• Completion: 2023-05-16
• First posted: 2022-11-09
• Last updated: 2023-07-27

Locations

1 site across 1 country: Egypt