An interventional study of Dexamethasone and NSAIDs in Tonsillitis Chronic, Tonsillitis Recurrent and OSA - Obstructive Sleep Apnea, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
A Prospective Randomized Controlled study. The study will be conducted at Ain Shams University hospital, Otolaryngology Department. Study period is 6 months from approval of the protocol. Study Participants will be recruited from outpatient ENT clinic, and ENT department inpatients.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 75 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Indications of tonsillectomy such as:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par
Procedure: Dexamethasone
2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.
Drug: NSAIDs
3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill
Drug: Control (Standard treatment)
1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and paracetamol.
Also known as: 1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and paracetamol.
2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.
Also known as: 2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.
3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department.
Also known as: 3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department.
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
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
Pt feedback after tonsillectomy
Patient satisfaction and return to normal activity.
Time frame: 2 weeks post operatively
Complications
Adverse effects noticed such as nausea, vomiting, infection and post tonsillectomy bleeding.
Time frame: 2 weeks post operatively
Plan to share: No
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Studies of the drug tested here: Anti-Inflammatory Agents, Non-Steroidal