Are probiotics useful post-tonsillectomy? – A randomised controlled study (feasibility trial)
Efficacy of probiotic gargles in reducing post-operative complications in adult post-tonsillectomy patients: A pilot triple-blinded, randomised controlled trial (feasibility trial)
Frankston Hospital
30 participants
Sep 23, 2019
Interventional
Conditions
Summary
Tonsillectomy is the most commonly performed otolaryngologic procedure. Despite advances in surgical techniques, the morbidity post-tonsillectomy remains high especially in the adult population. Pain remains the most consistent and incapacitating symptom experienced by patients post-operatively. This includes the need for analgesics as well as the inability to resume normal diet and activity for several days. Severe pain has been reported in 20% to 50% of children and young adults who have undergone tonsillectomy. There have been many studies investigating a variety of factors that influence post-tonsillectomy pain in the aim of reducing post-operative morbidity and requirement of rescue analgesics such as opiates, which can also have devastating effects. Hypothesis: For many years it has been suggested that post-tonsillectomy pain is further worsened by colonisation of tonsillar fossae with organisms that induce inflammatory response thereby making pain worse. Intervention: We aim to determine if using a probiotic gargle (Streptococcus salivarius) for 14 days post surgery reduces pain and reduces usage of rescue analgesics such as endone. Streptococcus salivarius is already established in the human oral cavity a few hours after birth and remains there as a predominant commensal inhabitant. This product comes in powder or lozenge form and is recommended for daily use. We aim to use the probiotic in powder form as a gargle to maximise contact with affected area (i.e. tonsillar fossa). The comparison group will use a placebo gargle (isomalt). A daily post-tonsillectomy diary will be sent daily via email or mobile phone to patients to complete. Patients who do not have access to email or mobile phone will be provided with hard copy of the questionnaire. If probiotics can reduce post-operative complications in adult tonsillectomy patient patients we would reduce morbidity, reduce requirement for opiate analgesia, prevent overuse of antibiotics and reduce substantial costs to the healthcare system.
Eligibility
Inclusion Criteria4
- Age 18-55
- Elective Tonsillectomy or adenotonsillectomy only
- Indication of operation (one of the following): asymmetric tonsillar enlargement, recurrent tonsillitis, previous quinsy (> one), sleep disordered breathing, halitosis, tonsillolith
- Weight must be more than 50kg.
Exclusion Criteria13
- Allergic to opioids / codeine / Endone™ / paracetamol
- Lactose intolerance
- Unstable metabolic diseases/disorder
- Heart failure or a history of endocarditis
- Immunocompromised
- Kidney disease
- Liver disease
- Hemorrhagic diathesis
- Other concomitant surgical procedures.
- Pregnancy
- Patients who are currently taking NSAIDs e.g.: Celebrex™, Aspirin, etc.
- Patients who are on regular opiates or Paracetamol
- Recent use of probiotics within 1 month
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Interventions
Intervention group – Probiotic (Streptococcus salivarius K12, BLIS) gargles: 2 scoop (Concentration will be 125 million CFU/scoop) dissolved in 20ml of warm water, gargle for 30 seconds and then swallow, four times a day for 14 days *1 Scoop equivalent to ¼ teaspoon Participant diaries and bottle returns will be used to monitor adherence to the intervention Participants will use the probiotic 24hrs after surgery
Locations(1)
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ACTRN12619001474145