Benzydamine Hydrochloride and Post-operative Sore Throat

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age21-80
SponsorKK Women's and Children's Hospital

About this trial

Postoperative sore throat (POST) after laryngeal mask airway (LMA) insertion is prevalent and unappealing. A significant cause of POST is mechanical injury to the airway mucosa during airway instrumentation, leading to mucosal injury and inflammation. The Difflam Forte Anti-Inflammatory Throat Spray (Difflam) contains benzydamine hydrochloride, a non-steroidal anti-inflammatory agent with topical analgesic properties. This study will randomize 106 women undergoing gynaecological surgery under general anaesthesia with LMA use at KK Women's and Children's Hospital (KKH) in 1:1 allocation ratio of study (Difflam spray) and control (usual practice; no intervention) groups. Demographic and intraoperative airway data collection will be conducted in perioperative period. Those allocated to study group will receive Difflam spray when awake in the post-anaesthesia care unit (PACU). The primary aim to determine if patients undergoing general anaesthesia with LMA use with the Difflam spray in PACU will have a lower incidence of POST in the immediate and 4 hours postoperative recovery period, as compared with those in the control group. Other outcome measures include the severity of pain of sore throat as measured by the visual analog scale, and incidence of side effects associated with the Difflam spray. This proposal will determine whether the use of Difflam spray is suitable to be implemented in local clinical setting and improve perioperative care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anaesthesiologists (ASA) physical status 1-2

Female patients having laryngeal mask airway (LMA) for airway management for surgery in KKH;

BMI < 40 kg/m2.

Disqualifiers

Pregnant;

Pre-existing sore throat, or history of upper respiratory tract infection/ abnormalities, hypertension, chronic pain or anti-inflammatory drugs and antihypertensive treatment;

Allergies to benzydamine hydrochloride;

Symptomatic hiatus hernia;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Benzydamine Hydrochloride

    Drug

    The Difflam Forte Anti-Inflammatory Throat Spray (iNova Pharmaceuticals Pte Ltd, Singapore) is an over-the-counter medication indicated for temporary relief of painful mouth and throat conditions. It contains benzydamine hydrochloride (BH) 3 mg/mL, a non-steroidal anti-inflammatory agent (NSAID), and is recommended for adults to spray 2 to 4 times to the affected throat every 1.5 to 3 hours as needed.

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Study groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Postoperative sore throat

Presence of postoperative sore throat (POST) during the immediate and 4 hours postoperative recovery period. At these two time points patients will be asked whether they have sore throat; and answering 'yes' will be considered as 'POST present'.

Time frame
1 day; from the immediate and 4 hours postoperative recovery period

Secondary outcomes

1

Postoperative pain score

Pain score during the immediate and 4 hours postoperative recovery period after intervention (Visual analog scale 0-10) will be asked, with zero being no pain, and 10 being the worst pain possible.

Time frame
1 day; from the immediate and 4 hours postoperative recovery period
2

Side effects

Presence of side effects during the immediate and 4 hours postoperative recovery period. At these two time points patients will be asked whether they have burning and/or stinging, dry mouth, cough, local numbness; and answering 'yes' will be considered as 'burning and/or stinging, dry mouth, cough, local numbness present'.

Time frame
1 day; from the immediate and 4 hours postoperative recovery period

Other outcomes

Sponsors and contacts

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