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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Hysterectomy
• Intervention / Treatment: Drug: Ketorolac Injectable Solution; Drug: Ibuprofen 800 mg

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Ahmed Mohamed Hasanin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adult (40-65 years)
• ASA I-II women
• scheduled to undergo open elective abdominal hysterectomy with or without salpingo-oophorectomy

Exclusion Criteria:

• renal impairment,
• allergy to any of study's drugs,
• history of gastrointestinal bleeding or ulceration, or inflammatory bowel disease,
• severe cardiac comorbidity (impaired contractility with ejection fraction < 50%, heart block, significant arrhythmias, tight valvular lesions),
• patients undergoing surgery for suspected gynaecological cancer,
• patients on chronic analgesic medication,
• inability to comprehend the Visual Analogue Pain Scoring Scale

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ketorolac group; ketorolac 30 mg	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
Active Comparator: Ibuprofen group; ibuprofen 800 mg	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean dynamic VAS	average postoperative VAS	24 hour after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
static VAS	a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')	30 minutes, 2, 4, 6, 10, 18, 24 hours postoperatively
dynamic VAS	a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')	procedure (during knee flexion)
time to first analgesia requirement	hours	period from extubation until first analgesic requirement during the first 24 hour postoperatively
morphine consumption	mg	during the first 24 hour postoperatively
time to independent movement	time from extubation to be able independently mobile e.g. using the bathroom	during the first 24 hour postoperatively
patients satisfaction	on scale of 0 to 10	at the end of 24 hour postoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2022
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): May 16, 2023

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Ibuprofen
• Other Study ID Numbers: MD-246-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data will be share upon reasonable request from the PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No