Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05610384
• Other study ID #: MD-246-2022
• Status: Completed
• Phase: N/A
• Start date: November 20, 2022
• Est. completion date: May 16, 2023

Study information

• Verified date: July 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 16, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hysterectomy
• Pain, Postoperative
• Postoperative Pain

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Ahmed Mohamed Hasanin	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean dynamic VAS	average postoperative VAS	24 hour after surgery
Secondary	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
Secondary	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)
Secondary	time to first analgesia requirement	hours	period from extubation until first analgesic requirement during the first 24 hour postoperatively
Secondary	morphine consumption	mg	during the first 24 hour postoperatively
Secondary	time to independent movement	time from extubation to be able independently mobile e.g. using the bathroom	during the first 24 hour postoperatively
Secondary	patients satisfaction	on scale of 0 to 10	at the end of 24 hour postoperative