The introduction and use of Entonox® as an alternative method of pain relief for intrauterine contraceptive device insertion.

Phase 1

• Conditions: 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; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-003628-29-GB
• Lead Sponsor: niversity of Brighton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-23
• Study Completion: 2016-08-04
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 51

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified