Postoperative Analgesic Effects of Ibuprofen Versus Ketorolac in Patients Undergoing in Orthopedic Surgery

NCT05695664 | Completed Early Phase 1

• 1 other identifier: 156/05/21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To compare the postoperative analgesic effects of ibuprofen versus ketorolac in patients undergoing orthopedic surgery at Combined Military Hospital, Rawalpindi. Study design: Randomized controlled trial Setting: Department of Anasthesiology, Combined military Hospital, Rawalpindi Duration of study:6 months (01st August 2021 to 31st January 2022) Material and methods: After ethical approval, 100 patients in randomly divided two equal groups (A and B) were selected. In group A, 800 mg IV ibuprofen while in group B, 30 mg IV ketorolac was given within 30 min of skin closure after orthopedic surgery. The pain was assessed via visual analogue scale postoperatively. The SPSS version 25 was used for analysis of data. P value ≤ 0.05 was considered as significant.

Conditions

Intravenous Drug Usage; Ibuprofen; Ketorolac; Knee Arthroscopy; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Postoperative pain

  Postoperative pain measured by visual analogue scale (VAS), in which 0 is no pain and 10 is the maximum possible bearable pain.

  3, 6 and 12 hours in postoperative period

• Rescue analgesia requirement

  Inj. Ketorolac 30 mg as Rescue analgesic was used intravenouly when VAS was equal or more than 4

  12 hours in the postoperative period

Study Arms (2)

Ibuprofen

EXPERIMENTAL

patient received 800 mg of Ibuprofen IV

Drug: Ibuprofen 800 mg

Ketorolac

EXPERIMENTAL

Patients received Keterolac 30 mg IV

Drug: Ketorolac Injection

Interventions

Ibuprofen 800 mg DRUG

Intravenous injection of ibuprofen 800 mg

Ibuprofen

Ketorolac Injection DRUG

Intravenous injection of Ketorolac 30 mg

Ketorolac

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either gender undergo orthopedic surgery were included in the study.
• ASA ≤ 2
• Age 40-80 years.
• Fracture Radius , Ulna, and wrist

You may not qualify if:

• Patients with history of adverse response from ketorolac and ibuprofen was not taken into the study.
• Patients with history of epilepsy.
• Patients with history of cardiac conduction defects.
• Patients on antiarrhythmic drugs or analgesics.
• Patients with H/O stroke, renal impairment, chronic obstructive pulmonary disease, asthma, chronic liver disease, hypothyroidism and CCF were excluded.

Sponsors & Collaborators

• Benazir Bhutto Hospital, Rawalpindi: lead
• Combined Military Hospital, Pakistan: collaborator

Study Sites (1)

Fazal Hussain

Bhakkar, Punjab Province, 300000, Pakistan

Location

Related Publications (5)

• Greimel F, Maderbacher G, Zeman F, Grifka J, Meissner W, Benditz A. No Clinical Difference Comparing General, Regional, and Combination Anesthesia in Hip Arthroplasty: A Multicenter Cohort-Study Regarding Perioperative Pain Management and Patient Satisfaction. J Arthroplasty. 2017 Nov;32(11):3429-3433. doi: 10.1016/j.arth.2017.05.038. Epub 2017 May 26.

  PMID: 28641966 BACKGROUND

• Hernandez-Boussard T, Graham LA, Desai K, Wahl TS, Aucoin E, Richman JS, Morris MS, Itani KM, Telford GL, Hawn MT. The Fifth Vital Sign: Postoperative Pain Predicts 30-day Readmissions and Subsequent Emergency Department Visits. Ann Surg. 2017 Sep;266(3):516-524. doi: 10.1097/SLA.0000000000002372.

  PMID: 28657940 BACKGROUND

• Masala IF, Caso F, Sarzi-Puttini P, Salaffi F, Atzeni F. Acute and chronic pain in orthopaedic and rheumatologic diseases: mechanisms and characteristics. Clin Exp Rheumatol. 2017 May-Jun;35 Suppl 105(3):127-131. Epub 2017 Jun 29.

  PMID: 28681710 BACKGROUND

• Lavie LG, Fox MP, Dasa V. Overview of Total Knee Arthroplasty and Modern Pain Control Strategies. Curr Pain Headache Rep. 2016 Nov;20(11):59. doi: 10.1007/s11916-016-0592-6.

  PMID: 27655139 BACKGROUND

• Ramia E, Nasser SC, Salameh P, Saad AH. Patient Perception of Acute Pain Management: Data from Three Tertiary Care Hospitals. Pain Res Manag. 2017;2017:7459360. doi: 10.1155/2017/7459360. Epub 2017 Mar 28.

  PMID: 28458592 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen; Ketorolac

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; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant General Surgeon

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 25, 2023
• Study Start: August 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)