This study is to investigate the efficacy of 2 methods of pain relief during the procedure of an intrauterine contraceptive device insertion (coil). There is no medical condition or disease under investigation
Conditions
Interventions
Trade Name: Entonox
Product Name: Nitrous Oxide (50%) and Oxygen (50%) mixture
Pharmaceutical Form: Inhalation vapour
INN or Proposed INN: Nitrous Oxide
Sponsors
University of Brighton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants will be women aged 18-54 years old, 54 years being the maximum age for IUC provision for women in East Sussex Healthcare NHS Trust Community Sexual Health Service as per professional guidelines (Faculty of Sexual and Reproductive Healthcare, 2010). Women requesting IUC as their preferred method of contraception. Women who fulfil the eligibility criteria for an IUCD insertion. Women requesting analgesia for IUCD insertion. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 58 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Any women not eligible for IUCD insertion. women less than 18 years of age or more than 54 years of age. Women who decline a local anaesthetic intracervical injection or decline to use an inhalation analgesic. Women for whom lidocaine local anaesthetic is contra-indicated, to include; -Known hypersensitivity to Lidocaine, or any other aesthetics of the amide type or any components of the injection. -Previous maximum infiltration of local anaesthetic within 4 hours. -Complete heart block or congestive cardiac failure. -Hypovolaemia. -Inflamed or infected tissue at injection site. -Participant on Fosamprenavir or Saquinavir. Women for whom Entonox is contra-indicated, to include; -women who cannot use a mouthpiece or who are unable to co-operate e.g. Intoxication. -Participants who have any condition where air is trapped in the body and its expansion would be dangerous E.G.; Underwater diving in last 24hrs. -Middle ear disease where there is blockage of the Eustation tube. -Use of central acting depressant and their derivatives E.G. strong opiate based medication/benzodiazepines. -Any use of Entonox within previous 4 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research objective is to see if Entonox® helps to reduce the level of pain experienced by women during intrauterine contraception device insertions in a community contraception and sexual health clinic compared to local anaesthetic intracervical injection.; Secondary Objective: The secondary objective is whether the use of a self administered and regulated analgesic (Entonox®) which empowers the patient to have control over their pain relief and management improves the overall satisfaction with pain relief received for this procedure. Additional areas for exploration are whether level of pain and analgesic efficacy is related to participants age, parity (number of pregnancies and mode of delivery) and/or previous intrauterine contraception device insertion experience. ;Primary end point(s): To measure pain scores at tenaculum placement and IUCD insertion using a 100mm VAS scores ;Timepoint(s) of evaluation of this end point: Evaluation will occur at two points within the procedure for IUCD insertion that are know to be potentially painful, tenaculum (surgical clamp) placement to the cervix to provide traction and stabilise the cervix and insertion of a uterine measuring device and contraceptive device through the cervix and into the uterus. End point will occur following insertion of the intrauterine contraceptive device. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To measure satisfaction with the procedure using 2 Likert scale questions. ;Timepoint(s) of evaluation of this end point: These questions will be asked following completion of the procedure. End point will be completion of the IUCD insertion appointment. | — |
Countries
United Kingdom
Contacts
Public ContactTheofanis Fotis
University of Brighton
Outcome results
None listed