Does paracetamol given by mouth before wisdom tooth extraction give equal pain relief compared to paracetamol given by intravenous infusion?
| ISRCTN | ISRCTN77607163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77607163 |
| Protocol serial number | RPC179 |
| Sponsor | Queen Victoria Hospital NHS Foundation Trust (UK) |
| Funder | National Institute for Health Research (UK) - the Research for Patient Benefit (RfPB) programme |
- Submission date
- 22/01/2008
- Registration date
- 09/05/2008
- Last edited
- 12/12/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Stephen Fenlon
Scientific
Scientific
Queen Victoria Hospital NHS Foundation Trust
Holtye Road
East Grinstead
RH19 3QE
United Kingdom
| stephen.fenlon@qvh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled, blinded trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A comparison of pre-medication with oral paracetamol versus intravenous paracetamol given at time of induction for post-operative analgesia following wisdom tooth extraction |
| Study objectives | There is no clinically significant difference between the post-operative analgesic effects of paracetamol when given orally as a pre-medication one hour pre-operatively, and when given as an intravenous infusion immediately pre-operatively. |
| Ethics approval(s) | Brighton East Research Ethics Committee approved as of 19th February 2008 (ref: 08/H1107/16) |
| Health condition(s) or problem(s) studied | Analgesia in wisdom tooth extraction |
| Intervention | Participants will be randomly assigned to either: 1. Oral pre-med group: two 500 milligram paracetamol capsules and 100 ml bag of normal saline for injection, or 2. IV group: two placebo lactose capsules and 100 ml (1 gram) of paracetamol for injection The oral pre-medication will be given one hour prior to surgery and the intravenous whilst the participant is under a general anaesthetic. Duration of treatment 15 minutes for intravenous injection. Duration of follow up until discharged from hospital (max 3 - 4 hours). |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Paracetamol |
| Primary outcome measure(s) |
We will compare the pain scores of patients in the two study arms one hour post-operatively. This will be done in recovery using a Visual Analogue Scale (VAS) pain scoring system. |
| Key secondary outcome measure(s) |
We will compare the time to request of post-operative rescue analgesia between the two study arms. Specifically, this will be measured from when the patient arrives in recovery. This point will serve as a standard time zero (t0). The time elapsed before the patient requests additional analgesia (if at all) will act as a secondary surrogate marker of analgesic efficacy. |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 116 |
| Key inclusion criteria | Patients over 18 years (either sex) having a general anaesthetic for extraction of wisdom teeth of which at least one must be a lower molar tooth. |
| Key exclusion criteria | 1. Patients who are unable to give full consent, or who do not wish to take part in the trial 2. Patients who have a baseline Visual Analogue Scale (VAS) score of more than zero 3. Patients unable to swallow tablets 4. Patients who have taken simple analgesics that day, prior to surgery 5. Hypersensitivity or history of serious adverse reactions to paracetamol or non-steroidal anti-inflammatory drugs 6. Active liver disease 7. Renal dysfunction 8. Pregnant or breast feeding women 9. Alcohol or drug abuse 10. History of unresponsiveness to paracetamol 11. Gastric or peptic ulcer disease 12. Inflammatory bowel disease 13. Blood coagulation abnormalities |
| Date of first enrolment | 31/03/2008 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Queen Victoria Hospital NHS Foundation Trust
East Grinstead
RH19 3QE
United Kingdom
RH19 3QE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
