A Prospective, Non-inferiority Randomized Double-blinded Trial Comparing Fentanyl and Midazolam vs Diazepam and Pethidine for Pain Relief During Oocyte Retrieval
Overview
- Phase
- Phase 4
- Intervention
- fentanyl
- Conditions
- Infertility
- Sponsor
- Kwong Wah Hospital
- Enrollment
- 170
- Primary Endpoint
- Pain Level After Oocyte Retrieval
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The objective of the trial is to compare fentanyl and midazolam vs diazepam and pethidine in terms of the pain levels and post-operative side effects of TUGOR
Detailed Description
In-vitro fertilization / embryo transfer (IVF / ET) is a well-established method to treat various causes of infertility. It involves multiple follicular development, retrieval of oocytes and embryo transfer after fertilization. Egg retrieval at the majority of IVF units is performed through the transvaginal route under ultrasound guidance (TUGOR) \[1\]. During TUGOR, the needle has to pass through the mucosa in the vaginal vault in order to puncture the follicles in the ovary. The procedures are generally short, lasting about 20-30 minutes but are still painful without anaesthesia or analgesia. Intravenous sedation with or without local anaesthesia is the most widely used method. Conscious sedation is a safe and cost-effective method of providing analgesia and anesthesia for TUGOR. \[2\] It is easy to administer in cooperative and motivated patients. It has a relatively low risk for adverse effects on oocyte and embryo quality and pregnancy rates. \[3\] Paracervical block (PCB) in conjunction with conscious sedation during TUGOR was shown to significantly reduce the pain during TUGOR when compared to PCB alone \[4\]. A Cochrane review on various methods of sedation and analgesia for pain relief during TUGOR has shown no single method or delivery system appeared superior for pregnancy rates and pain relief. \[5\] Most of the methods seemed to work well and the effect was usually enhanced by addition of another method such as pain relief with paracervical block. \[6\] The investigators' reproductive centre has recently aligned with the Assisted Reproduction Centre of the University of Hong Kong (HKU). The investigators are using 0.1mg fentanyl and 5mg midazolam intravenously for pain relief in TUGOR at Kwong Wah Hospital (KWH) whereas 5mg diazepam and 25mg pethidine intravenously are being used in HKU. The investigators would like to compare fentanyl and midazolam vs diazepam and pethidine in terms of pain levels and post-operative side effects of TUGOR in this prospective non-inferiority randomized double-blinded trial. The investigators postulate there are no differences in the pain levels between two groups but the postoperative side effects may be different.
Investigators
lydia lai
Associate Consultant
Kwong Wah Hospital
Eligibility Criteria
Inclusion Criteria
- •presence of both ovaries;
- •body mass index less than 30
- •written informed consent and
Exclusion Criteria
- •IVF cycle converted from ovulation induction or intrauterine insemination cycles;
- •patient requests general anaesthesia for TUGOR;
- •history of drug sensitivity to lignocaine/fentanyl/midazolam/diazepam/pethidine;
- •less than 3 dominant follicles present;
- •dominant follicles present in one ovary only and
- •TUGOR performed on one side only.
Arms & Interventions
A: intravenous fentanyl, midazolam
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
Intervention: fentanyl
A: intravenous fentanyl, midazolam
group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval
Intervention: Midazolam
B: intravenous pethidine, diazepam
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
Intervention: pethidine
B: intravenous pethidine, diazepam
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval
Intervention: Diazepam
Outcomes
Primary Outcomes
Pain Level After Oocyte Retrieval
Time Frame: will be assessed within 4 hours of oocyte retrieval
The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful
Pain Level During Oocyte Retrieval
Time Frame: will be assessed within 4 hours of oocyte retrieval
The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful
Secondary Outcomes
- Patient's Satisfaction on Pain Relief(within 4 hours after retrieval)
- Patient's Satisfaction on Oocyte Retrieval(will be assessed within 4 hours of oocyte retrieval)
- Percentage of Participants With Side Effects by Type(will be assessed within 4 hours of oocyte retrieval)
- Clinical Pregnancy Rate(will be assessed within ten weeks of oocyte retrieval)
- Sedation Level(immediately after retrieval)
- Ongoing Pregnancy Rate(will be assessed within ten weeks of oocyte retrieval)