The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorAin Shams University

About this trial

The aim of this study is to compare the efficacy of adding paracetamol to systemic non-steroidal anti-inflammatory drugs (NSAIDs) versus adding dexamethasone as local infiltration to paracetamol on post tonsillectomy pain control.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: Between 4-10 years.

Recurrent acute attacks at least 7 episodes in the past year or at least 5 episodes per year for 2 years or at least 3 episodes per year for 3 years.

Chronic tonsillitis and hypertrophy of tonsils causing sleep apnea, difficulty in deglutition, interference in speech.

Tonsillectomy by cold dissection only.

Disqualifiers

Patients with age less than 4 and more than 10 years.

Indications of tonsillectomy other than chronic tonsillitis such as lymphoma.

Patients on chronic steroid therapy

Hemoglobin level less than 10 gm/dL

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone

    Procedure/Surgery

    1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and paracetamol.

  • NSAIDs

    Drug

    2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.

  • Control (Standard treatment)

    Drug

    3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: 1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and parExperimental treatment 1 intervention
Group B: 2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and antExperimental treatment 1 intervention
Group C: 3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

post tonsillectomy pain

The primary endpoints that will be used is resting pain scores using virtual analogue scale; VAS score (0: no pain-10: worst pain) at DAY 0 after 6h, 24h and DAY 5 post-operatively. Where pain score will be measured at multiple points during the outcome intervals, the pain scores at the time closest to six and 24h will be used.

Time frame
DAY 0 6h, 24h post-operatively and DAY 5 post-operatively

Secondary outcomes

1

Additional pain medication needed

The percentage of the patients in group 1 and 2 that will need extra analgesia

Time frame
2 weeks post operatively
2

Pt feedback after tonsillectomy

Patient satisfaction and return to normal activity.

Time frame
2 weeks post operatively
3

Complications

Adverse effects noticed such as nausea, vomiting, infection and post tonsillectomy bleeding.

Time frame
2 weeks post operatively

Other outcomes

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