IV Ibuprofen vs Ketorolac in Post Operative Pain in Colorectal Cancer Surgeries in Obese Patient

NCT05782608 | Completed

• 1 other identifier: MS-503-2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the Efficacy of IV Ibuprofen and Ketorolac in the Management of Postoperative Pain in obese patients Following abdominal cancer surgery.

Conditions

Ibuprofen; Ketorolac; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Assessment of Pain

  Pain using visual analogue score (VAS score), Using a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).

  During procedure

Study Arms (2)

group (I)

ACTIVE COMPARATOR

Drug: IV ibuprofen

group (II)

ACTIVE COMPARATOR

Drug: IV ketorolac

Interventions

IV ibuprofen DRUG

Group 1 will receive IV ibuprofen 400mg \\ 6 hours the first dose will be administrated immediately post operative.

group (I)

IV ketorolac DRUG

Group 2 will receive 20 mg IV ketorolac\\ 6 hours the first dose will be administrated immediately post operative

group (II)

Eligibility Criteria

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

You may qualify if:

• ASA class II.
• Age ≥ 18 and ≤ 65 Years.
• Patients undergoing midline abdominal incision for colorectal cancer surgery.
• Body mass index (BMI) \>30 kg/m2.

You may not qualify if:

• Renal and hepatic insufficiency.
• Unstable cardiovascular disease.
• History of psychiatric and cognitive disorders.
• Patients allergic to medication used.
• Asthmatic patients.
• Peptic ulcer patients.
• patients on regular opioid consumption.
• History of allergy or hypersensitivity to any component of ibuprofen, other NSAIDs, opioids or COX- 2 inhibitors.
• Subjects with active significant anemia, history of asthma .

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Mahmoud Ismail Salama

Cairo, 11511, Egypt

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Ibuprofen; Ketorolac

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

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: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of anesthesia, SICU & Pain Management

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: March 23, 2023
• Study Start: April 1, 2023
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: one year

Locations

EG (1)