Comparison of Pain-Reducing effect between Topical Ethyl Chloride Spray versus Subcutaneous 1% Lidocaine Injection during Two Rods System Contraceptive Implant Insertion: A Randomized Controlled Trial.

Phase 4

Completed

• Conditions: Pain; Ethyl Chloride Spray; Lidocaine; Two rods system implant; Anesthetic administration pain

• Registration Number: TCTR20201218001
• Lead Sponsor: one

Brief Summary

All basic clinical characteristics between the two groups showed no significant difference. Mean VAS during anesthetic in the Ethyl Chloride Spray (ECS) group were significantly lower than in the Lidocaine injection (LI) group (3.92 and 2.89, p 0.01). However, the mean VAS during; (1) implant insertion, (2) 20 min after implant insertion and (3) overall pain, in the ECS group were significantly higher than in the LI group (4.83, 1.61, 3.11 versus 0.98, 0.09, p 0.01)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-18
• Study Completion: 2021-07-19
• Results First Posted: 2022-01-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

1.Thai literate women over 18 Years with parental or caregiver permission who prefer to use two rods system contraceptive implant.
2.No contraindication for one rod system implant.

Exclusion Criteria

1.Known allergic to either analgesic methods.
2.Removal and reinsertion of subdermal implant at the same time.
3.Received pain killer within 4 hours prior to the procedur.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Score durring Analgesic application Analgesic application 10 cm Visual Analogue Scale for Assessment of Pain Intensity,Pain Score durring Implant insertion Implant insertion 10 cm Visual Analogue Scale for Assessment of Pain Intensity,Pain Score 20 minutes after implant insertion 20 minutes after implant insertion 10 cm Visual Analogue Scale for Assessment of Pain Intensity,Overall Pain Score 20 minutes after implant insertion Pain Score calculated from Pain Score during Analgesic application, Implant insertion and 20 minutes after implant insertion