Different Analgesics Prior to Intrauterine Device (IUD) Insertion: Is There Any Evidence?

Different Analgesics Prior to IUD Insertion: Is There Any Evidence?

Different ways of reducing pain during IUD insertion have been explored. So a randomized study will be conducted to test their role

Study Overview

• Status: Unknown
• Conditions: IUD Insertion Complication
• Intervention / Treatment: Drug: Lidocaine; Drug: oral misoprostol; Drug: naproxen; Other: placebo

Detailed Description

A randomized clinical controlled trial of women undergoing IUD insertion. Participants in the study groups will be randomly assigned by labeled opaque envelopes to either1% lidocaine (Xylocaine 1%, Astra Zeneca, Egypt), misoprostol (Sigma, Egypt), naproxen (Naprosyn, Syntax, Egypt) or placebo tablets.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Shebin Elkom, Egypt
    • Recruiting
    • Menoufia University
    • Contact: nabih elkholy, MD; Phone Number: 00201060868443
• Saudi Arabia
  • Abha, Saudi Arabia
    • Recruiting
    • Alhayah national hospital
    • Contact: mohamed maher; Phone Number: +966558198655
    • Contact: tarek sayyed
    • Principal Investigator: mohamed maher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Patients are considered eligible if:

1. they are alert oriented and co-operative to response to the visual analogue scale (VAS).
2. They will sign the informed consent to participate in the clinical trial before entering the study.
3. Willingness to be randomized and complete study questionnaires.

Exclusion Criteria:

Participants are excluded from participation if they are ineligible for an IUD by accepted criteria of our institution such as:

1. A lidocaine allergy
2. Copper allergy
3. Current cervicitis
4. Pelvic inflammatory disease (PID) within 3 months
5. Uterine anomalies
6. Pain medication within 6 hours before insertion
7. Misoprostol administration within 24 hour before insertion
8. History of cervical surgery and contraindication to study medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lidocaine group; Group A will receive 10 ml 1% lidocaine (Xylocaine 1%, Astra Zeneca, Egypt) Para cervical block prior to insertion of IUD (injection sites at cervix-vaginal junction typically at 4 ,8 O'clock), Then 3 minutes waiting period between the administration of the Para cervical block and IUD insertion,	Drug: Lidocaine; intracervical injection
Active Comparator: misoprostol group; Group B will receive 400 mcg oral misoprostol (Sigma, Egypt) prior to IUD insertion	Drug: oral misoprostol; oral treatment
Active Comparator: non steroid group; Group C will receive oral naproxen (Naprosyn, Syntax, Egypt) prior to IUD insertion	Drug: naproxen; oral treatment
Placebo Comparator: placebo group; group D will receive placebo tablets.	Other: placebo; oral treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
current pain level with IUD insertion and 15 minutes post procedure measured by the Visual Analogue Scale.	A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range to across a continuum of values and can not easily to be directly measured. Subjects pain using a 10 point visual analogue scale (-+VAS, anchors: 0=non, 10 = worst imaginable). The participants were asked to mark their pre IUD insertion pain expectancies initially, then to mark their pain during different steps of IUD placement.	15 minutes

Collaborators and Investigators

• Sponsor: Al Hayat National Hospital
• Collaborators: Menoufia University

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Estimate): June 22, 2016
• Last Update Submitted That Met QC Criteria: June 21, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gastrointestinal Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Gout Suppressants; Oxytocics; Lidocaine; Misoprostol; Naproxen
• Other Study ID Numbers: ob/gyn4