A Phase 3 interventional study of Intravenous paracetamol and Intranasal Paracetamol in Tonsil Disease, Pain Management and Intranasal Drug Administration, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Bezmialem Vakif University · Phase 3, Interventional, and Treatment
This study aims to evaluate the efficacy and safety of intranasal Diclofenac Sodium, intranasal Ibuprofen, and intranasal Paracetamol for pain control following tonsillectomy in pediatric patients.
Postoperative pain management in pediatric tonsillectomy remains a challenge, with concerns about the safety and efficacy of available analgesic options. Intranasal administration of nonsteroidal anti-inflammatory drugs presents a promising alternative for effective pain relief with minimal side effects.
This prospective, randomized study evaluated the efficacy and safety of intranasal diclofenac sodium, intranasal ibuprofen, and intranasal paracetamol compared to intravenous paracetamol in pediatric patients following tonsillectomy. Sixty patients, aged 2 to 14 years, were divided into four groups to receive either intranasal paracetamol (Group 1), intranasal diclofenac sodium (Group 2), intranasal ibuprofen (Group 3), or intravenous paracetamol (Group 4). Pain was assessed using the CHEOPS, VAS, and Wong-Baker modified VAS scoring systems at various postoperative time points. Statistical analysis was performed using the Kruskal-Wallis and Dunn's tests.
1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.
This study's enrollment of 60 is below the median of 75 across 1,089 interventional studies indexed under Agnosia.
Browse Agnosia studies →Bezmialem Vakif University is the lead sponsor of 351 studies on the registry; 57 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
-Pediatric patients who have undergone a tonsillectomy.
Exclusion Criteria:
Participants in this arm received intranasal paracetamol (1.25 mg/mL) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery.
Drug: Intranasal Paracetamol
Participants in this arm received intranasal diclofenac sodium (0.0625 mg/mL) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery.
Drug: Intranasal Diclofenac Sodium
Participants in this arm received intranasal ibuprofen (0.375 mg/mL) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery.
Drug: Intranasal Ibuprofen
Participants in this arm received intravenous paracetamol (20 mg/kg/day, twice daily) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery.
Drug: Intravenous paracetamol
Paracetamol was administered intravenously at a dose of 20 mg/kg/day, twice daily.
Also known as: intravenous paracetamol (Group 4)
Paracetamol at a concentration of 1.25 mg/mL was administered intranasally.
Diclofenac sodium at a concentration of 0.0625 mg/mL was administered intranasally.
Ibuprofen at a concentration of 0.375 mg/mL was administered intranasally.
Children's Hospital of Eastern Ontario Pain Scale measurements
CHEOPS consists of a total of 6 categories of behaviour, with specific score ranges for each. The total score ranges from 6 to 16. A score of 16 means a lot of pain, while 4 means no pain.
Time frame: Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery).
VISUAL ANALOGUE Scale measurements
The patient indicates the level of pain by marking it on a visual scale, with one end of the line labelled 'No Pain' (0) and the other end labelled 'Intolerable Pain' (10). 0: No pain at all. 1-3: Mild pain. 4-6: Moderate pain. 7-10: Severe pain.
Time frame: Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery).
Wong-Baker Facial Pain Scale (Modified VAS) measurements
It is an adapted version for children. Pain is graded on the basis of different facial expressions (happy face → crying face). A happy face means no pain, while a crying face means a lot of pain.
Time frame: Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery).
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — I plan to share the excel file where the results are collected and made understandable
Supporting information: Statistical analysis plan, Informed consent form
Access criteria: The period of completion of the study and data analysis 30 December 2024-15 January 2025
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Acetaminophen · Diclofenac · Ibuprofen