Contact information
Type
Scientific
Primary contact
Dr Steve McDonald
ORCID ID
Contact details
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
stevemcdonald001@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0203157782
Study information
Scientific title
Acronym
Study hypothesis
In patients who have nasal surgery requiring nasal packing, which nose pack is the least uncomfortable to have removed: Netcell or Rapid-Rhino?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgery: Nasal
Intervention
Patients meeting the inclusion criteria will be recruited into a randomised controlled trial, in which one nasal cavity is packed with Netcel, and the other with Rapid-Rhino.
Patients deemed suitable will be approached for their consent to participate in the trial. A record of all such patients will be kept, along with reasons for the decline to take part if this occurs, in line with the CONSORT recommendations. All patient-sensitive data stored will be anonymous.
Randomisation
This will occur at the end of the procedure, when the surgeon decides to definitely pack both sides of the nose. If this is desired, the pack chosen for the left nostril would be selected by telephone randomisation. The pack chosen for the right nostril would be, by default, the other type of pack.
Removal of packs
As per current departmental practice, the packs will be removed by the nursing staff at 7am the following morning. Five minutes prior to removal, and immediately following removal, patients will record their pain scores on a standard 10cm visual analogue scale (an unmarked line), with the 2 ends to signify no pain and the most severe pain imaginable. Patients will mark the same line for both the left and right sides of the nose, and label each mark accordingly. The scales for the pre- and post- removal scores will be on opposite sides of a piece of paper to avoid the scores influencing one another. The left pack will always be removed first. It is possible that the order in which the packs are removed could influence the level of pain felt when the two sides are compared. Always removing the left pack first will ensure that this source of bias is eliminated.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Difference in mean Visual analogue score (VAS) on removal of pack
Secondary outcome measures
Not provided at time of registration
Overall trial start date
02/02/2005
Overall trial end date
02/08/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Patients having septal surgery and trimming of inferior turbinates will be identified when they attend for pre-assessment clinic. They will be given the information about the trial at that point and given time to consider if they wish to take part before signing the consent form. Inclusion criteria will include:
1. Patients aged 16-65. Children and older adults excluded as pain responses are known to differ at extremes of age.
2. Patients undergoing septal surgery with bilateral inferior turbinate surgery. All consultants in the department routinely pack following this procedure, whereas preferences differ for other nasal operations.
This limited inclusion criterion also ensures that the same operation is carried out on each side of the nose.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
45
Participant exclusion criteria
1. Revision surgery
2. History of a bleeding tendency
3. Patients on anticoagulants or anti-platelet drugs
4. History of sino-nasal trauma
5. Underlying systemic/sino-nasal disease such as Wegner's disease, sarcoidosis, fungal sinusitis
Recruitment start date
02/02/2005
Recruitment end date
02/08/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Devon & Exeter Healthcare NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19382493
Publication citations
-
Results
McDonald SE, Slater J, Powell R, Khalil HS, Garth RJ, A randomised controlled trial comparing Rapid Rhino Mannheim and Netcell series 5000 packs following routine nasal surgery., Rhinology, 2009, 47, 1, 41-44.