Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy

NCT ID: NCT05610384

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-20
• Study Completion Date: 2023-05-16

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Ketorolac group

ketorolac 30 mg

Group Type: ACTIVE_COMPARATOR

Ketorolac Injectable Solution

Intervention Type: DRUG

ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes before induction of anesthesia then every 8 hours postoperatively

Ibuprofen group

ibuprofen 800 mg

Group Type: ACTIVE_COMPARATOR

Ibuprofen 800 mg

Intervention Type: DRUG

ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes before induction of anesthesia then every 8 hours postoperatively.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hasanin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Mohamed Hasanin

Cairo, , Egypt

Countries

Egypt

References

Amin S, Hasanin A, Attia OA, Mostafa M, Elzayat NS, Elsherbiny M, Eissa AA. Intravenous ibuprofen versus ketorolac for perioperative pain control in open abdominal hysterectomy: a randomized controlled trial. BMC Anesthesiol. 2024 Jun 7;24(1):202. doi: 10.1186/s12871-024-02571-0.

Reference Type: DERIVED

PMID: 38849734 (View on PubMed)

Other Identifiers

MD-246-2022

Identifier Type: -

Identifier Source: org_study_id