A comparative study of safety and patient satisfaction of combined intramuscular acetaminophen- diclofenac versus acetaminophen-pentazocine for pain relief during manual vacuum aspiration in university of Maiduguri teaching hospital: Randomised controlled

*Corresponding author: Onah Livinus Nnanyereugo Copyright © 2025 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution License 4.0. (RESEARCH ARTICLE) A comparative study of safety and patient satisfaction of combined intramuscular acetaminophendiclofenac versus acetaminophen-pentazocine for pain relief during manual vacuum aspiration in university of Maiduguri teaching hospital: Randomised controlled study Maduka Chike Joachim 1, Onah Livinus Nnanyereugo 2, * and Ezugwu Ifeanyi Anthony 3 1 Department of Obstetrics and Gynaecology, Faculty of clinical Science, University of Maiduguri Teaching Hospital, Maiduguri, Borno State, Nigeria. 2 Department of Obstetrics and Gynaecology, Faculty of clinical Medicine Enugu State University Teaching Hospital/College of medicine, Enugu State Nigeria. 3 College of Medicine Enugu State University Teaching Hospital, ESUTH, Parklane, Enugu, Nigeria. World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 242-252 Publication history: Received on 25 February 2025; revised on 05 April 2025; accepted on 08 April 2025 Article DOI: https://doi.org/10.30574/wjbphs.2025.22.1.0378 Abstract Background. The management of first trimester miscarriages using manual vacuum aspiration is a cheap, fast and safe surgical method of uterine evacuation. However, this procedure cause pain as a result of cervical manipulation, insertion of cannula and suctioning of uterine cavity. Therefore, an effective and safe pain management intervention is necessary to minimise this pain and reduces side effect of the medication. Objective: To determine and compare the side effects and participants’ satisfaction of combined acetaminophendiclofenac versus acetaminophen-pentazocine for pain relief during manual vacuum aspiration. Methodology: This was a triple-blind randomised controlled study, that compared the side effects and participant satisfaction of combined acetaminophen-diclofenac versus acetaminophen-pentazocine as a multimodal analgesia during manual vacuum aspiration. A total of 112 participants were randomised into two groups. Participants in group A (56 patients) received combined acetaminophen-diclofenac while participants allocated in group B (56 patients) received acetaminophen-pentazocine for pain relief during manual vacuum aspiration. The outcome measured were the side effects and participants’ satisfaction with analgesia given during the procedure. The data was entered into SPSS version 20.0 (IBM, Armonk, NY, USA 2011) for statistical analysis. Result: Participants in combined acetaminophen-diclofenac group had less side effects compared to participant in combined acetaminophen-pentazocine group, and it was statistically significant for dizziness (P value = 0.001), nausea (P value=0.046) and weakness (P value=0.001). There was statistically significant difference in participants satisfaction in both groups (P value = 0.009). Greater number 48(85.7%) of participants in the acetaminophen-pentazocine group were satisfied compared to 36(64.3%) participants in the acetaminophen-diclofenac group. Conclusion: Combined acetaminophen-pentazocine as a form of analgesia during MVA provided more satisfaction, although it had a higher side effect profile, when compared to combined acetaminophen-diclofenac. Keywords: MVA; Acetaminophen; Diclofenac; Pentazocine; Side effect; Patient satisfaction World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 242-252 243 1. Introduction Miscarriage is the most common early pregnancy complication, which can be traumatizing to women and their clinicians.1 Miscarriage is defined as loss of intrauterine pregnancy before the age of viability.1 In Nigeria, age of viability is 28 weeks from the first day of the last normal menstrual period.2 About 10-20% of known pregnancies end in miscarriage,3 most of these occurrences happen in first trimester.3 Complications related to miscarriage continue to make considerable contributions to maternal morbidity and mortality in Sub-Saharan Africa.4,5 . Miscarriage is of great worry particularly in low resource countries because it can end in partial expulsion of products of conception, which may lead to excessive bleeding and infection.6 There are numerous methods that is currently available for management of first trimester miscarriages. These include: manual vacuum aspiration, electrical vacuum aspiration, sharp dilation and curettage and medical uterine evacuations.7 Manual vacuum aspiration (MVA) is a safe, fast, and cheap surgical method of uterine evacuation in first trimester abortion.7,8,9 It is associated with few incidences of serious complications, reduced need for general anaesthesia and shorter duration of hospital stay when used as the mode of treatment of abortion.8,10 Although it possesses all these good qualities, it causes pain during the procedure due to manipulation of the cervix and uterine suction.10 About 97 % of women who undergo manual vacuum aspiration without analgesia report pain during the procedure.11 The severity of pain experienced by women during surgical evacuation of uterine content differs with individuals. Post abortion care providers should create pain management plan together with the patients through discussion and clinical assessment before the procedure.12 All patients need adequate analgesia during manual vacuum aspiration and according to the Royal College of Obstetricians and Gynaecologists, analgesia should be provided for both medical and surgical uterine evacuations.13 Adequate pain relief during the procedure is an essential aspect of managing miscarriages, as this will provide maximum satisfaction with minimal risk to the patients’ health.11,13 There are various ways of managing pain during surgical uterine evacuation in miscarriage. They are divided into nonpharmacological and pharmacological methods. Non-pharmacological method also known as verbal anaesthesia, consists of verbal reassurance and gentle appropriate clinical technique.14 Pharmacological methods involves the use of opioids, nonsteroidal anti-inflammatory drugs(NSAIDs), local anaesthesia (paracervical block), and general anaesthesia.14 It is not always possible to provide a range of pain control options in every setting therefore, individualising pain medications as much as possible will go a long way in improving patient’s satisfaction with manual vacuum aspiration experience.15 World Health Organisation and RCOG recommendation on safe abortion favours local analgesia or parenteral sedation over general anaesthesia because they have been shown to minimise procedural and postoperative pain and still remain safe and satisfactory to patients.16 General anaesthesia is not routinely used for MVA because of the risks, costs, and clinical logistics of general anaesthesia. Local anaesthesia in form of paracervical block can be used for manual vacuum aspiration, as for other day care gynaecology procedures due to short duration of the procedure.12,16,17 However, injection of paracervical block into the cervical tissue targets parasympathetic fibres from S2 to S4 that supply the lower part of uterine body and cervix, thus reducing pain caused by cervical dilation and movement. More so, paracervical block cannot totally access sympathetic fibres from T10 to L1 that run through inferior hypogastric nerve and ovarian plexus innervating uterine fundus and lower part of uterine body.16,17 Therefore, sufficient pain relief with paracervical block during MVA will need extra analgesics. 16 Choice of analgesia used during manual vacuum aspiration is guided by safety, availability, cost, doctor preference, individual preference, history of drug allergy or departmental/institutional protocol.18,19 In developing countries, the ideal analgesia should be safe, cheap, easily administered, and require minimal resuscitative equipment.18 Multimodal approach using a combination of various analgesia and different classes of drugs have been recommended for pain management.16,18 The multimodal approach was recommended in order to provide a synergistic effects with reduced side effect profile of each of the drugs.18 The unimodal technique is commonly used in our environment.7 Opioids are very effective analgesics and a primary component of multimodal pain management in surgical settings.16,18 However, they are associated with many undesirable side effects such as dizziness, nausea, vomiting, pruritus, and drowsiness.18,20 Acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) are other classes of drugs that can be used in resource-constrained societies during MVA.7,18,20 Acetaminophen and NSAIDs are non-opioid analgesic devoid of any major adverse effects like respiratory and circulatory depression and has no sedative effect making them ideal for day care procedure with mild to moderate pain.20 World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 242-252 244 In 2013, a retrospective study carried out at the department of Obstetrics and Gynaecology University of Maiduguri Teaching Hospital on experience with manual vacuum aspiration noted that intramuscular pentazocine or paracetamol was the analgesia used during MVA.7 This current study was a randomised controlled study and multimodal analgesia was used during the procedure. Gynaecological emergency protocols produced at the department of Obstetrics and Gynaecology, University of Maiduguri Teaching Hospital, described MVA as a mode of treatment for miscarriage less than 12 weeks gestation but did not state a protocol for analgesia to be used during the procedure.21 However, pentazocine or diclofenac is the common current pain management practices during the procedure. A study has not been conducted in our center to assess the safety and participants satisfaction of the common drugs use for pain management during manual vacuum aspiration. Therefore, the aim of this study is to compare side effects and participants satisfaction of combined acetaminophen-diclofenac versus acetaminophen-pentazocine as a type of multimodal analgesia for management of pain, in patients undergoing manual vacuum aspiration. The outcome of the study may assist to form a departmental protocol on the safety and patient satisfaction on pain management during manual vacuum aspiration and other field in gynaecological practices that involve manipulation of cervix. Findings from the study will add to the existing literature upon which subsequent research work in the same area can be conducted and assist in policy formulation. 2. Material and methodology 2.1. Study design This was a triple blind randomised controlled equivalence study conducted from 15th April 2022 to August 20th 2022 to compare the side effects and participant satisfaction of intramuscular acetaminophen-diclofenac versus acetaminophen-pentazocine for pain relief during manual vacuum aspiration. 2.2. Study area and setting The study was carried out in Maiduguri, Borno state. Maiduguri metropolis (Latitude 11.85oN, Longitude 13.156oE) is located in North-Eastern Nigeria. Major ethnic groups within the state are the Kanuri and Shuwa Arabs, while other ethnic communities include Babur, Marghi, Fulani, Hausa, Isge, Chibok. Farming, fishing and trading are the major occupation of the people of the state. The University of Maiduguri Teaching Hospital is a tertiary hospital located in a densely populated area within Maiduguri metropolis. The hospital is an 800-bed capacity health institution. The Obstetrics and Gynaecology department run an antenatal, Gynaecological, family planning as well as oncology clinics. There is also a labour ward where deliveries or Obstetrics emergencies are managed and Gynaecological emergency clinic where Gynaecological emergencies are managed. Patients are attended to at any time they present to the Gynaecological emergency clinic by nurses and doctors on duty. Over one thousand nine hundred (1,900) patients present to the Gynaecological emergency clinic annually, with an average of ten patients in a day, out of which 2-4 require MVA. This study was carried out at the Gynaecological emergency clinic of the department of Obstetrics and Gynaecology, University of Maiduguri Teaching Hospital. The Gynaecological emergency clinic has five beds. Women attending the Gynaecological emergency clinic in our centre were properly evaluated, in-depth history taken, clinical examination and ultrasound scan done. Laboratory investigations were also carried out. Patients with diagnosis of miscarriage by clinical evaluation using a combination of last menstrual period, uterine size and pelvic ultrasound scan and require MVA had the procedure carried out in Gynaecological emergency treatment room. The cases were first seen by the house officer and then subsequently reviewed by the registrar, senior registrar, and then communicated to the managing consultant. 2.3. Study population The subjects were pregnant women who attend Gynaecological emergency clinic, that were diagnosed with miscarriage and require MVA. 2.4. Sample size determination The sample size was calculated based on the formula below23: World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 242-252 245 n= n= minimum sample size for each arm of the study group. α= probability of making type I error. β= probability of making type II error. Za= level of significance of type I error probability; determined from a statistical table based on the value of the level of significance a; for this study, it is set at 0.05. The 95% confidence interval (Za) =1.96 for a two-tailed test. Zb= this is type II error probability. It is determined from a statistical table based on the acceptance power of comparison between the two groups. For this study, a power of 80% (0.8) was used; therefore, Zb = 0.84. PT= proportion of participants in the study group (acetaminophen-diclofenac) who exhibited the primary outcome of interest from a previous study18; 64.4% (0.644) PS= proportion of participants in the control group (acetaminophen-pentazocine) who exhibited the primary outcome of interest from a previous study18; 40% (0.4) was used. δ: clinically admissible margin of equivalence (0.8-1.25). In this study, it is taken as ‘1.1’. 𝑃 = 𝑝𝑠+ 𝑝𝑟 2 𝑃 = 0.644 +0.4 2 = 1.044/2 = 0.522 1-P = 10.522 = 0.478 P(1-P) = 0.522(0.478) = 0.2495 PT-PS = (0.644– 0.4 ×1.15)2 =0.08 Therefore, 2 (1.96+0.842)20.522(0.478) 0.08 = 50 With ten percent attrition rate, the total sample size was 56 per group. (100/90×50) =5000/90=56. The total sample size was 112 participants. 2.5. Study procedure Approval for the study was obtained from the ethics and research committee of the UMTH before the study was carried out. Nurses covering gynaecological emergency clinic and four junior residents served as research assistants during the period of the study. Prior to the commencement of the study, the research assistants were trained for two days on the study protocol by the researcher. This training includes; introduction to the study, patients’ inclusion criteria, study procedures, intervention, participant satisfaction and side effect of analgesia used for the study. Adequacy of training was confirmed by preand posttesting of trainees. Participants was counselled and requested to sign a written informed consent, before recruitment into the study. A senior resident doctor covering the gynaecology emergency or on call, who is not part of the research assistants, was responsible for obtaining informed consent from a participant prepared for MVA in the Gynaecology emergency clinic before the participant underwent MVA. The women were assured that they could opt out of the study when they desired to do so, without any consequence. One of the nurses on duty was responsible for the withdrawal of the study drugs into 5 milliliters disposable syringes that were provided for the study by the researcher. She was trained to withdraw the drugs into the syringes, label the syringes A(acetaminophen-diclofenac) or B(acetaminophen-pentazocine) and discard the ampoules into a safety box at the Gynaecological emergency treatment room without allowing the other nurse know the drug contained in each of the syringes. She then handed over the two syringes containing the study drugs to the second nurse on duty to administer to the participants. World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 242-252 246 2.6. Intervention 2.6.1. Group A All eligible participants were given intramuscular acetaminophen (DrugfieldR) 600 mg and intramuscular diclofenac sodium (Voltaren) 75 mg 20 minutes before the procedure at the upper lateral gluteal region. 2.6.2. Group B All eligible participants were given intramuscular acetaminophen (DrugfieldR) 600 mg and intramuscular pentazocine (Zolon) 60 mg 20 minutes before the procedure at the upper lateral gluteal region. Manual vacuum aspiration was performed according to standard protocol by the junior resident covering the Gynaecology emergency or junior resident on call. All participants, regardless of assigned analgesia given, were managed according to the gynaecological emergency protocol of University of Maiduguri Teaching Hospital. Intravenous access with a wide bore cannula size was secured, while taking blood for packed cell volume, blood grouping and cross matching. Urinalysis was also done. Each participant was placed in lithotomy position. Bimanual pelvic examination was done. The perineum and vagina were cleaned with antiseptic solution and draped with sterile towel. Cusco’s speculum was gently inserted into the vagina. The anterior or posterior lip of the cervix was held with tenaculum to straighten the endocervical canal depending on the position of the uterus. An appropriately sized Ipas Easy Grip cannula was inserted into the uterine cavity using non-touch technique and attached to the charged vacuum syringe. Uterine evacuation was done by rocking and rotatory movements of the cannula. Signs of completion of the procedure were aspiration of red or pink foam without more tissue seen the cannula, gritty sensation was felt, and uterus contracts around the cannula. The cannula, tenaculum and speculum were removed after confirming evidence of complete uterine emptying. The aspirated tissue was examined and sent for histology. Vital signs were monitored every 15 minutes in the first one-hour, then hourly for next 3 hours post operatively. All participants were given analgesia, antibiotics and haematinics. Also, injection anti D immunoglobulin was given to rhesus negative patients (all according to the department’s protocol). All participants were monitored in the gynaecological emergency ward for 4 hours. Thirty minutes after completion of the procedure, the participant was assessed on her satisfaction with the procedure using Likert chart scale and side effects of the study drugs such as dizziness, nausea, vomiting, shivering, and diarrhoea. They were asked about their level of satisfaction with the type of analgesia used during the procedure. The following three questions to evaluate each woman’s satisfaction: “How satisfied are you with this treatment?” The answers concerning satisfaction was graded as: very satisfied, satisfied, equivocal, unsatisfied and very unsatisfied. 1 and 2 are tagged yes (satisfied), 3,4 and 5 are tagged as no (unsatisfied). The answer chosen for the two latter questions was ‘yes’ or ‘no’. 24 2.7. Inclusion criteria The following inclusion criteria was applied; Women diagnosed with miscarriage clinically and/or by pelvic ultrasound scan at a gestational age of 12 weeks or less that requires MVA. Patients that are informed, counselled, and consented to participate in the study. 2.8. Exclusion criteria The following criteria was excluded; • Known peptic ulcer disease patients • Allergic reaction to pentazocine, diclofenac and acetaminophen. • Septic or hypovolemic shock • Patients with chronic liver or kidney disease • Known coagulation disorder RANDOMISATION: Pregnant women scheduled for manual vacuum aspiration for miscarriage in Gynaecology emergency clinic were counselled and informed written consent was obtained from them. A computer-generated World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 242-252 247 random number using Stat Trek random numbers generator (manufactured by Stat Trek) was used to assign women to either intramuscular acetaminophen - diclofenac group or intramuscular acetaminophen-pentazocine group as A and B respectively. The allocation was written on cards and placed in consecutively numbered opaque sealed envelopes and kept by the research assistant. The research assistants (junior residents) that had been trained by the researcher removed the next envelope at random from the box and women who meet the inclusion criteria were assigned to the group indicated on the card in the study envelope. The participants, researcher and data analyst were blinded to the intervention. Blinding of participants: In order to blind the participants, the two drugs were of the same color, same volume in the same size of 5mls syringes and were administered 20 minutes before starting the procedure. Both drugs were administered intramuscularly and both drugs are not known to be painful at the site of injection. Blinding of the assessors and data analyst: The assessors were the researcher and research assistants (junior resident doctors). They were blinded by exclusion from participants recruitment and drug administration. There was a separate treatment sheet for drugs given to the participants before the procedure to further blind the assessors from the study. Data was sent to the data analyst as either group A or B. Research drugs: Procurement of drugs was through pharmacy department of UMTH, who have the responsibility of pre-qualifying drugs products and brands before use in the hospital. The brands selected were of the same batch and shelf live. Storage of the drugs were at well controlled ambience temperature specific of the selected drug products and drugs destruction was also through pharmacy department of UMTH. Outcomes: The outcome was to determine and compare incidence of dizziness, nausea, weakness, vomiting, and participant satisfaction with analgesia regimen used when either combined intramuscular acetaminophen-diclofenac or acetaminophen-pentazocine was given for pain relief during manual vacuum aspiration. DATA COLLECTION AND ANALYSIS: Data was obtained by interviewing the participants and from the participants’ record. The data was then transferred to a proforma. Information pertaining to the socio-demographic variables of the participants, management and outcome were extracted. The data was entered into SPSS version 20.0 (IBM, Armonk, NY, USA, 2011) for statistical analysis. Simple frequency tables were generated. Participants’ characteristics were presented as numbers and percentages for categorical data, and as mean with standard deviations (SD) for continuous normally distributed data. Comparison was made using student t-test for continuous variables and chi-square or Fisher's exact test, as appropriate was used to analyse the variables which were grouped into categories. The analysis was done based on “intention -to-treat” principle. 2.9. Ethical approval and study registration Approval of this study was obtained from the Ethics committee of the University of Maiduguri Teaching Hospital (UMTH). All records were identified only by code number and initials to maintain confidentiality. Women were reassured that no clinical information would be divulged without their express permission. First aid box was provided to manage emergency complication of the drugs if it occurs. The study was registered with the Pan African Clinical Trial Registry (www.pactr.org). My unique identification number for the registry is PACTR202209818432344. 3. Result A total number of 140 women diagnosed to have miscarriage that required manual vacuum aspiration were assessed for eligibility, ten (10) women did not meet eligibility criteria while eighteen (18) women declined to participate in the study. One hundred and twelve participants with miscarriage that require manual vacuum aspiration were recruited for the study with 56 participants randomly assigned to either acetaminophen-diclofenac or acetaminophen pentazocine treatment group. Each participant received the allocated treatment. Table 1 shows a comparison of the demographic characteristics of the participants in the two study groups. There was statistically significant difference in the age of participants and the mean age in both groups were 30.50±7.55 years and 27.77±6.30 years respectively (P = 0.043). There was no statistically significant difference in estimated gestational age and parity in both groups. World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 242-252 248 Figure 1 Flow chart of participants assigned to acetaminophen-diclofenac (Group A) versus acetaminophenpentazocine (Group B) during MVA Table 1 Demographic characteristic of participants in acetaminophen-diclofenac (Group A) versus acetaminophenpentazocine (Group B) during MVA Variables Group A Group B SST P Value Age(years) (Ẍ ± SD) 30.50±7.55 27.77±6.30 4.234** 0.043 EGA (weeks) (Ẍ ±SD) 8.96±1.54 9.07±1.48 0.378** 0.818 Parity Nullipara Para 1-4 ≥Para 5 12(21.4%) 33(59.0%) 11(19.6%) 12(21.4%) 37(66.1%) 7(12.5%) 1.117* 0.572 SST = Statistical Test, *Chi square, **student-t test; EGAEstimated gestational age. P value=< 0.05 World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 242-252 249 Table 2 shows a summary of the indications for manual vacuum aspiration in both groups. There was a statistically significant difference in the indications for manual vacuum aspiration (P value =0.017). The commonest indication for manual vacuum aspiration for both groups was incomplete miscarriage, accounting for 85.7% and 69.6% in group A and group B respectively. Blighted ovum was diagnosed in 14.3% in group A and 17.9% in group B, while 12.5% was diagnosed with missed miscarriage in group B. Table 2 Indications for Manual Vacuum Aspiration (MVA) in both groups Variables Group A n (%) Group B n (%) ꭓ2 P Value Incomplete miscarriage 48(85.7) 39(69.6) Blighted ovum 8(14.3) 10(17.9) 8.153 0.017* Missed miscarriage 0(0.0) 7(12.5) Total 56(100) 56(100) ꭓ2 = 8.153, P = 0.017, *Statistically significant at < 0.05 Table 3 shows the side effects of the study drugs experienced by participants in both groups when used for pain relief during manual vacuum aspiration. Overall, the table showed that participants in Group B had more side effects when compared to participants in group A. There was statistically significant difference for dizziness, nausea and weakness. However, there was no statistically significant difference for vomiting, headache and heartburn. Table 3 Comparing Side effects of acetaminophen-diclofenac (Group A) versus acetaminophen-pentazocine (Group B) during MVA Variables Group A n (%) Group B n (%) χ2 P Value Dizziness 2(3.6) 37(66.1) 48.19 0.001* Nausea 14(25.0) 24(42.9) 3.98 0.046* Vomiting 0(0.0) 3(5.4) 0.24** 0.079 Headache 1(1.8) 0(0.0) 1.00** 0.315 Weakness 0(0.0) 14(25.0) 0.00** 0.001* Chest pain or Heart burn 2(3.6) 0(0.0) 0.49** 0.154 **=Fischer exact test, *Statistically significant at < 0.05 Table 4 shows participant’s satisfaction with the form of analgesia used during manual vacuum aspiration in both groups. There was a statistically significant difference between the two groups (P value=0.009) when the level of participants satisfaction experienced during the procedure was assessed. Participant’s satisfaction was better in group B 48 (85.7%), compared to group A 36 (64.3%). Participants in group A 20 (35.7%) were more unsatisfied compared to participants in group B 8 (14.3%). Table 4 Comparison of level of satisfaction when either acetaminophen-diclofenac (Group A) versus acetaminophenpentazocine (Group B) is used during MVA Variables Group A n (%) Group B n (%) χ2 P Value Satisfied 36(64.3) 48(85.7) Unsatisfied 20(35.7) 8(14.3) 6.857 0.009* Total 56(100.0) 56(100.0) *Statistically significant at < 0.05 World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 242-252 250 4. Discussion In this study, there were no major complications in either of the groups. However, the number of participants that reported dizziness, nausea, and weakness were significantly higher among the acetaminophen-pentazocine group compared to acetaminophen-diclofenac group and the difference was statistically significant. Participants that received diclofenac in other studies reported lesser side effects than participants that was given pentazocine or other opioids.18,22 This is not surprising because pentazocine is an opioid and these are known side effects of opioids.26 This finding in my study was similar to that in Qurrat-ul-Ain et al and Adamou et al that reported fewer side effects in the acetaminophendiclofenac groups.22,27 High percentage (66.1%) of participant in acetaminophen-pentazocine group in this study had dizziness and this is lower than 86.6% reported to have dizziness in the study by Natalia et all in pentazocine only group.18 The differences could be due to individual variation in developing side effect of the drug. The quality of pain management can be assessed by participants satisfaction.22 In this study, participant satisfaction was better in acetaminophen-pentazocine group compared to the acetaminophen-diclofenac group. This is similar to findings by Natalia et al, which showed that when a combination of pentazocine and diclofenac was used, participants had more satisfaction, compared to when a single agent was used.18 This is contrary to a study by Qurrat-ul-Ain et al in which participants in diclofenac group had higher satisfaction than those in tramadol (an opioid) group, though single agent was used for analgesia during the manual vacuum aspiration.22 The dose of tramadol in the above study was 100mg and diclofenac was 100 mg. Diclofenac was given rectally and tramadol was given parenterally (Intramuscular). Route of administration can affect pain perception, thus affect satisfaction during manual vacuum aspiration, as was observed by Qurrat-ul-Ain et al and another study. 22,28 This may be the reason for better satisfaction in diclofenac group compared to tramadol group in that study. 22,28 Superior pain relief has been reported to be associated with better participant satisfaction, 18,22,26 as was seen in this study. The high satisfaction experienced by participant in acetaminophen-pentazocine group shows that the treatment offered to patients fulfilled their health needs and this will enable them present to the hospital for further health needs and to advise and recommend treatment methods to friends or family members that need manual vacuum aspiration. Other factors that might contribute to participant satisfaction include short hospital stay and few side effects, that are not life-threatening28 as was seen in this study. 5. Conclusion Based on the results of this study, it can be concluded that combined acetaminophen-pentazocine as a form of analgesia during MVA had a higher side effect profile, although provides more satisfaction when compared to combined acetaminophen-diclofenac. Limitation and strength of the study The limitation of this study was that it is a single centre study and did not represent all the women in Borno state that need manual vacuum aspiration for surgical uterine evacuation, especially low-income women that receive free medical services in the state-owned hospitals. The strength of this study was that it is a triple blind, randomised controlled study. Recommendation A multicentre, triple blind controlled study comparing the side effects and participants satisfaction of the study drugs is recommended for stronger generalisation and conclusion Compliance with ethical standards Disclosure of conflict of interest There was no conflict of interest Statement of informed consent Informed consent was obtained from all individual participants included in the study.