Prevention of pain on injection with propofol: Comparison of lignocaine with dilution using 0.9% Sodium Chloride
| ISRCTN | ISRCTN19276105 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19276105 |
| Secondary identifying numbers | N0234131723 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 30/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A P Madden
Scientific
Scientific
Department of Anaesthetics
North Bristol NHS Trust
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
| Phone | +44 (0)117 959 5114 |
|---|---|
| abc@email.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Prevention of pain on injection with propofol: Comparison of lignocaine with dilution using 0.9% Sodium Chloride |
| Study objectives | Will the dilution of Fresenius 1% propofol using equal parts of 0.9% Sodium Chloride and 1% Fresenius propofol reduce the incidence of pain on injection in children aged 5 to 10 years? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory: Pain |
| Intervention | Children aged 5-10 years (up to approximately 30 kg) will be randomised to either a sample or control group. A single blinded observer will then watch for signs of discomfort on induction of anaesthesia during the injection of propofol. This will be defined as a motor response of the arm, a verbal complaint of pain, a cry and or grimace. |
| Intervention type | Other |
| Primary outcome measure | A reduction in the incidence of pain on injection of Propofol when compared with the most commonly used and effective method in current practice (i.e. the addition of lignocaine - 2 ml 1% per 20 ml propofol). |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2003 |
| Completion date | 01/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Children aged 5-10 years (up to approximately 30 kg) with American Society of Anesthesiologists (ASA) status 1 or 2 on elective surgical lists. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/11/2003 |
| Date of final enrolment | 01/07/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Anaesthetics
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
North Bristol NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
30/03/2020: No publications found. All search options exhausted.
