Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management

NCT03178539 | Completed Phase 2 DMC

• 1 other identifier: 17100114
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Compare between the analgesic efficacy of diclofenac sodium and ketorolac tromethamine in post-tonsillectomy pain management.and Compare between the effect of diclofenac sodium and ketorolac tromethamine on post-tonsillectomy bleeding

Conditions

Pain, Acute

Keywords

tonsillectomy; post operative analgesia; diklofanic; ketorolac

Outcome Measures

Primary Outcomes (1)

• pain relieve

  the verbal rating scale (VRS; 0 = no pain, 1 = mild pain, 2 = moderate pain, 3= severe pain, and lastly 4= excruciating pain). VRS assessment will be performed immediately postoperative and 3, 6, 12 and 24h postoperatively

  24 hours

Secondary Outcomes (2)

• bleeding

  two weeks

• dysphagia

  two weeks

Study Arms (2)

diclofenac

ACTIVE COMPARATOR

patients will receive intra-operative diclofenac sodium at dose of 0.3 mg/kg intravenously then will continue postoperatively on the same drug received intra-operative.

Drug: diclofenac

ketorolac

ACTIVE COMPARATOR

patients will receive intra-operative ketorolac tromethamine at dose of 0.5 mg/kg intravenously then will continue postoperatively on the same drug received intra-operative.

Drug: ketorolac

Interventions

diclofenac DRUG

non steroidal anti-inflammatory drug

Also known as: Voltaren

diclofenac

ketorolac DRUG

non steroidal anti-inflammatory drug

Also known as: Tromethamine

ketorolac

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children scheduled for elective tonsillectomy\\adenotnsillectomy for chronic or recurrent tonsillitis and aged between 6 to 12 years

You may not qualify if:

• Known hypersensitivity to medication drugs.
• Coagulation disorders, thrombocytopenia or active bleeding for any cause.
• Bronchial asthma.
• Significant cardiac, renal, pulmonary, hepatic disease or peptic ulcer.
• The use of any analgesic medications within 24h preoperative or antiplatelet medication within the past 2 weeks.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Asyut Governorate, 715715, Egypt

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Diclofenac; Ketorolac; Tromethamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propylene Glycols; Glycols; Alcohols

Study Officials

• Hala S Abdel_Ghaffar, MD

  Assistant professor, faculty of medicine, Assiut university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 7, 2017
• Study Start: January 31, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)