Title: USE OF NAPROXEN VERSUS INTRACERVICAL BLOCK FOR PAIN CONTROL
DURING THE 52-MG LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM
INSERTION IN YOUNG WOMEN: A MULTIVARIATE ANALYSIS OF A RANDOMIZED
CONTROLLED TRIAL
Version: 2 Date: 19 May 2021
Reviewer:  Hisham Haggag
Reviewer's report:
I have read with interest your manuscript titled “USE OF NAPROXEN
VERSUS INTRACERVICAL BLOCK FOR PAIN CONTROL DURING THE 52-MG
LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM INSERTION IN YOUNG
WOMEN: A MULTIVARIATE ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL”
I congratulate the authors on their work but I have a few comments waiting for their reply.
In the introduction section:
1. Please rephrase line 55 as it needs some linguistic modifications
2. Line 68 please change “experienced” to “active”
3. Line 79-81; recently Samy et al., 2020 have showed that dinoprostone (a similar drug to
misoprostol) was effective in reducing pain in a similar population. [1]
4. In the aim of the study I strongly recommend that you remove the terms “oral analgesia” and
“local anesthesia” from your manuscript and just use the drugs’ names.
In the patients and methods section:
1. Line 97, 98 what do you mean by uterine cavity distortion and what are the contraindications
to use of progestin?
2. Your exclusion criteria are lacking eg why didn’t you remove patients with gastritis or peptic
ulcers?
3. Why did you choose to do block randomization and not simple randomization? Where you
planning to do the analysis earlier?
4. Please give details for the procedure of cervical block eg speculum use, tenaculum .. etc.  Was
it done before the sounding?
5. During sample size calculation why did us assume such a diference? Was it on personal
experience or previous literature?
In the results section:
1. Regarding the malpositioned LNG-IUS, could this be the cause of less pain eg cervical
placement which will be nearly painless?
2. Why did you use medians and means for pain scores? I believe means are enough.
3. Please use the terms “white skin” and “skin of colour”
4. I find the weight and height of your sample very confusing? Were all your patients 1.62 m
SD 0.1 m? please just state the mean and SD of the BMI.
5. What are your units for uterine sounding? I assumed it is cm. How did you evaluate it to the
nearest 0.1 mm?
6. Table 2, the second variable is a repetition. Please remove it.
7. Similarly in table 3 the second variable; no need to stratify the VAS.
In the discussion section: “generally concise but well written”
1. Line 224, in 2019 a network meta-analysis contradicts your statement. [2]
2. What do you think are your strengths?
References:
1. Samy A, Ali AS, Latif D, Darweesh FF, Ghamry NK, Metwally AA. Benefits of Self-
administered Vaginal Dinoprostone 12 Hours before Levonorgestrel-releasing Intrauterine
Device Insertion in Nulliparous Adolescents and Young Women: A Randomized Controlled
Trial. J Pediatr Adolesc Gynecol. 2020 Aug;33(4):382-387. doi: 10.1016/j.jpag.2020.02.010.
Epub 2020 Feb 28. PMID: 32113878.
2. Samy A, Abbas AM, Mahmoud M, Taher A, Awad MH, El Husseiny T, Hussein
M, Ramadan M, Shalaby MA, El Sharkawy M, Hatem D, Alaa-El-Din Wali A, Abd-El-
Fatah SM, Hussein AH, Haggag H. Evaluating different pain lowering medications during
intrauterine device insertion: a systematic review and network meta-analysis. Fertil Steril.
2019 Mar;111(3):553-561.e4. doi: 10.1016/j.fertnstert.2018.11.012. Epub 2019 Jan 2. PMID:
30611553.