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

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ClinicalTrials.gov Identifier: NCT03178539
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Hala Saad Abdel-Ghaffar, Assiut University

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

Condition or disease Intervention/treatment Phase
Pain, Acute Drug: diclofenac Drug: ketorolac Phase 2 Phase 3

Detailed Description:

patients will be randomly allocated to two groups of 50 patients each Group (A): will receive intra-operative diclofenac sodium at dose of 0.3 mg/kg intravenously.

Group (B): will receive intra-operative ketorolac tromethamine at dose of 0.5 mg/kg intravenously.

Then the two groups will continue postoperatively on the same drug received intra-operative

I. Intra-operative data:

Bleeding score will be assessed by the surgeon at the end of the operation using the following Scale for bleeding assessment (0 = no bleeding, 1 = bleeding as usual, 2 = bleeding more than usual, 3 = profuse, 4 = excessive, and lastly 5 = excessive and continuous).

II. Early Post-operative data:

  1. Post- tonsillectomy bleeding assessments;

    • Bleeding score will be recorded immediately postoperative and 3, 6, 12 and 24h postoperatively.
    • Hospital re-admission because of bleeding.
    • Re-operation because of bleeding.
  2. Post- tonsillectomy pain assessments; Pain intensity will be assessed postoperatively by 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. Analgesia will be given if requested or if the VRS≥2. Patients in Group A will receive diclofenac sodium 0.3 mg/kg iv, while patients in Group B will receive ketorolac tromethamine 0.5 mg/kg.

The total consumption of analgesics used in each group in the first 24 h postoperative will be calculated and the time of the first request for analgesia will be recorded.

  • Time to first oral intake.
  • Total intake of food in the 1st 24h postoperatively (solids vs. semisolids).

IV. Late Post-operative data:

As aweekly follow up for 2 weeks :

  1. bleeding tendency
  2. Dysphagia.

    • Time needed to restore normal dietary habits

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: diclofenac
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
non steroidal anti-inflammatory drug
Other Name: Voltaren

Active Comparator: ketorolac
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
non steroidal anti-inflammatory drug
Other Name: Tromethamine




Primary Outcome Measures :
  1. pain relieve [ Time Frame: 24 hours ]
    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


Secondary Outcome Measures :
  1. bleeding [ Time Frame: two weeks ]
    Bleeding score will be assessed by the surgeon at the end of the operation using the following Scale for bleeding assessment (0 = no bleeding, 1 = bleeding as usual, 2 = bleeding more than usual, 3 = profuse, 4 = excessive, and lastly 5 = excessive and continuous).

  2. dysphagia [ Time Frame: two weeks ]
    time needed to restore normal dietary habbit



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178539


Contacts
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Contact: Ahmed H Hussein Khalifa, MBBCH 01140964494 ahmed_hussein20172017@yahoo.com
Contact: hala S Abdel-ghaffar, MD 01003812011 hallasaad@yahoo.com

Locations
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Egypt
Assiut university hospital Recruiting
Assiut, Asyut Governorate, Egypt, 715715
Contact: Ahmed H Khalifa, MBBCH    01140964494    Ahmed_hussein20172017@yahoo.com   
Contact: Hala S Abdel_ghaffar, MD    01003812011    hallasaad@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Hala S Abdel_Ghaffar, MD Assistant professor, faculty of medicine, Assiut university

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Responsible Party: Hala Saad Abdel-Ghaffar, assistant professor, Assiut University
ClinicalTrials.gov Identifier: NCT03178539     History of Changes
Other Study ID Numbers: 17100114
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hala Saad Abdel-Ghaffar, Assiut University:
tonsillectomy
post operative analgesia
diklofanic
ketorolac
Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action