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Completed

NCT Number: NCT03178539

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

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

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut university hospital

Asyut, Asyut Governorate, 715715, Egypt

About this study

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:

  • 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.
  • 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≥3. 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 needed to restore normal dietary habits.

IV. Late Post-operative data:

As aweekly follow up for 2 weeks :

  • bleeding tendency
  • Dysphagia.
  • Time needed to restore normal dietary habits

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diclofenac

Drug

non steroidal anti-inflammatory drug

Other names: Voltaren

Ketorolac

Drug

non steroidal anti-inflammatory drug

Other names: Tromethamine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2017
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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