Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy

NCT05610384 | Completed

• 1 other identifier: MD-246-2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain; Hysterectomy

Outcome Measures

Primary Outcomes (1)

• mean dynamic VAS

  average postoperative VAS

  24 hour after surgery

Secondary Outcomes (6)

• static VAS

  30 minutes, 2, 4, 6, 10, 18, 24 hours postoperatively

• dynamic VAS

  procedure (during knee flexion)

• time to first analgesia requirement

  period from extubation until first analgesic requirement during the first 24 hour postoperatively

• morphine consumption

  during the first 24 hour postoperatively

• time to independent movement

  during the first 24 hour postoperatively

Study Arms (2)

Ketorolac group

ACTIVE COMPARATOR

ketorolac 30 mg

Drug: Ketorolac Injectable Solution

Ibuprofen group

ACTIVE COMPARATOR

ibuprofen 800 mg

Drug: Ibuprofen 800 mg

Interventions

Ketorolac Injectable Solution DRUG

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

Ketorolac group

Ibuprofen 800 mg DRUG

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

Ibuprofen group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

Location

Related Publications (1)

• 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.

  PMID: 38849734 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 9, 2022
• Study Start: November 20, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 16, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)