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Post tonsillectomy pain control – a double blinded , randomised, prospective study

Does the use of COX-2 inhibitors Celecoxib (Celebrex(Trademark) improve the outcome of post tonsillectomy pain? A double-blinded randomised control study in patients over 18 years of age.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000600741
Enrollment
80
Registered
2013-05-27
Start date
2013-06-20
Completion date
2015-04-29
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study looks at the treatment of post tonsillectomy pain. The pain experienced is severe and has a tendency to get worse five to seven days after surgery. This often has an impact on the patient’s oral intake prolonging the return to normal activity. The narcotics given for pain control are often associated with side effects. Non-steroidal anti-inflammatory drugs, such as Celecoxib (Celebrex(trademark) are superior for the control of pain minus the side effects. In this study the patient will be randomised to one of two groups and given a study pack on discharge. Both packs contain an antibiotic (Penicillin) and a “rescue” analgesic (Oxycodone - Endone(Trademark) ). One pack contains paracetamol and one contains paracetamol and Celecoxib/Celebrex. Patients will be asked to chart their recovery until their pain ceases. A data collection chart will be given to each patient on discharge. Each patient will be followed up in outpatients 5 days and 4 weeks post-surgery.

Interventions

The administration of a non-steroidal anti-inflammatory drugs, celecoxib,( Celebrex(trademark)) , for the control of post tonsillectomy pain Post operatively, patients will receive regular analgesics routinely given to post tonsillectomy patients. with allowance for IV Morphine as rescue analgesia, Ondansetron / Maxalon Metoclopramide (taken orally) as antiemetic and other medications deemed necessary.. 2 doses of IV Dexamethasone 8mg will be given to all patients post-operatively and on the f

The administration of a non-steroidal anti-inflammatory drugs, celecoxib,( Celebrex(trademark)) , for the control of post tonsillectomy pain Post operatively, patients will receive regular analgesics routinely given to post tonsillectomy patients. with allowance for IV Morphine as rescue analgesia, Ondansetron / Maxalon Metoclopramide (taken orally) as antiemetic and other medications deemed necessary.. 2 doses of IV Dexamethasone 8mg will be given to all patients post-operatively and on the first morning post surgery. Upon discharge patients will be supplied with a treatment or placebo pack. Both packs contain Paracetamol (1gm (4 times per day) 12 days), Penicillin (500mg (twice per day) 5 days), endone (5mg (as required) /6 hrly) and either Placebo (2 capsules (twice per day) 7 days) OR Celecoxib ((200 mg capsules), 2 capsules (twice per day), 7 days)). All medications are taken orally Study participants will be asked to return all unused medications to the study coordinator at the final outpatient appointment. These will be checked against their patient drug diary to ensure protocol adherence.

Sponsors

Department of Surgery Frankston Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Over 18 years Undergone a tonsillectomy

Exclusion criteria

(1) Other concomitant surgical procedures (2) Allergic to NSAIDS/opioids/codeine/endone/paracetamol/sulphonamide (3) Asthma (4) Kidney disease (5) Liver disease (6) Cardiovascular disease (7) Hemorrhagic disease (8) Hypertension (9) OSA (10) Women trying to conceive, pregnant or nursing (11) Patients taking clebrex

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026