Comparison of Analgesic Effects between Nalbuphine and Sufentanil in First-Trimester Surgical Abortion: A Randomized, Double-Blind, Controlled Trial

IntroductionRecurrent miscarriage (RM), defined by three or more consecutive losses during the first trimester of pregnancy, affects 1%–2% of fertile couples. Standard investigations fail to reveal any apparent cause in ~50% of couples. However, on the basis of animal models and clinical studies, several hypotheses have been put forward concerning underlying mechanisms of RM: altered ovarian reserve, progesterone defect, thrombotic and/or endothelial dysfunction and immunological disturbances. Nonetheless, no study has yet reached conclusive beneficial clinical evidence for a potential treatment in unexplained RM. Hydroxychloroquine (HCQ) is a molecule with extensive safety data during pregnancy. The pharmacological properties of HCQ (eg, antithrombotic, vascular protective, immunomodulatory, improved glucose tolerance, lipidlowering and anti-infectious) could be effective against some mechanisms of unexplained RM. Furthermore, eventhough clinical benefit of HCQ is suggested in prevention of thrombotic and late obstetric events in antiphospholipid (APL) syndrome, there are no data suggesting the benefit of HCQ in RM in the presence of APL antibodies.Methods and analysisTaken all together and given the low cost of HCQ, the aim of this multicentre, randomised, placebo-controlled, double-blind study is to investigate whether HCQ would improve the live birth rate in women with RM, irrespective of maternal thrombophilic status: (1) no known thrombophilia, (2) inherited thrombophilia or (3) APL antibodies. The primary end point is a live and viable birth. After confirming eligibility and obtaining consent, 300 non-pregnant women will be randomised into two parallel groups for a daily oral treatment (HCQ 400 mg or placebo), initiated before conception and stopped at 10 weeks’ gestation. If pregnancy does not occur after 1 year, the treatment will be stopped.Ethics and disseminationAgreement from the French National Public Health and Drug Security Agency (160765A-22) and ethical approval from the Committee for the Protection of Persons of NORD-OUEST I (2016-001330-97) have been obtained.Trial registration numbersNCT0316513; Pre-results.

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A randomized double-blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-016-1509-8 ◽

2016 ◽

Vol 17 (1) ◽

Cited By ~ 6

Author(s):

Diana Man Ka Chan ◽

Ka Wang Cheung ◽

Sofie Shuk Fei Yung ◽

Vivian Chi Yan Lee ◽

Raymond Hang Wun Li ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Study Protocol ◽

Controlled Trial ◽

First Trimester ◽

Double Blind ◽

Randomized Controlled ◽

Threatened Miscarriage

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Music as an auxiliary analgesic during first trimester surgical abortion: a randomized controlled trial

Contraception ◽

10.1016/j.contraception.2011.11.017 ◽

2012 ◽

Vol 86 (2) ◽

pp. 157-162 ◽

Cited By ~ 25

Author(s):

Jacqueline M. Guerrero ◽

Paula M. Castaño ◽

Elizabeth O. Schmidt ◽

Linette Rosario ◽

Carolyn L. Westhoff

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

First Trimester ◽

Randomized Controlled ◽

Surgical Abortion

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Early analgesic effects of intravenous parecoxib and rectal diclofenac following laparoscopic sterilization: A double-blind, double-dummy randomized controlled trial

Journal of Opioid Management ◽

10.5055/jom.2008.0008 ◽

2018 ◽

Vol 4 (1) ◽

pp. 49

Author(s):

Alexander Ng, MD, FRCA ◽

Ajay Swami, FFARCSI ◽

Graham Smith, MD, FRCA ◽

Joe Emembolu, FRCOG

Keyword(s):

Randomized Controlled Trial ◽

Pain Intensity ◽

Controlled Trial ◽

Double Blind ◽

Rescue Analgesia ◽

Analgesic Effects ◽

Randomized Controlled ◽

Significant Difference ◽

Laparoscopic Sterilization ◽

Rescue Antiemetic

The aim of this double-blind double-dummy randomized controlled trial was to investigate if there was any difference in analgesia between the maximum recommended doses of rectal diclofenac and iv parecoxib after laparoscopic sterilization. The authors studied 55 ASA I-II patients undergoing gynecological laparoscopy; each patient received either preoperative rectal diclofenac 100 mg and 2 mL of normal saline at induction of anesthesia, or preoperative placebo suppository and 2 mL of parecoxib 40 mg at induction. Pain intensity, sedation, and nausea were measured using a 100-mm visual analogue scale on awakening and at 1, 2, and 3 hour postoperatively. Median (interquartile range) pain intensity at rest on awakening and at 1, 2, and 3 hour postoperatively were 15 (0-40), 37 (10-56), 16 (6-29), and 13 (2-32) mm, respectively, in the parecoxib group, and 3 (0-34), 22 (5-45), 24 (6-37), and 10 (4-21) mm, respectively, in the diclofenac group. There was no significant difference in these scores. Furthermore, there was no significant difference between the two groups in sedation, nausea, rescue analgesia, or rescue antiemetic consumption. Preoperative rectal diclofenac 100 mg and parecoxib 40 mg iv at induction of anesthesia were found to have equianalgesic effects after laparoscopic sterilization. Both drugs appear to be useful after short anaesthetics.

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