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 Table of Contents  
REVIEW ARTICLE
Year : 2022  |  Volume : 12  |  Issue : 4  |  Page : 102-116

The effect of sumatriptan, theophylline, pregabalin and caffeine on prevention of headache caused by spinal anaesthesia (PDPH): A systematic review


1 Department of Anesthesia, School of Paramedical Sciences, Arak University of Medical Sciences, Arak, Iran
2 Department of Anesthesiology, School of Nursing and Midwifery, Arak, Iran
3 School of Nursing and Midwifery, Arak, Iran
4 Department of Epidemiology, School of Health, Arak University of Medical Sciences, Arak, Iran
5 Department of Anesthesiology, Shahid Beheshti Hospital, Qom University of Medical Sciences, Qom, Iran

Date of Submission05-Sep-2022
Date of Acceptance10-Oct-2022
Date of Web Publication23-Nov-2022

Correspondence Address:
Dr. Rahmatollah Moradzadeh
Department of Epidemiology, School of Health, Arak University of Medical Sciences, Arak
Iran
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jwas.jwas_183_22

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  Abstract 

Spinal anaesthesia (SA) is a common method during surgery due to easy administration, rapid effects, relaxes muscles and controls pain. But, post-dural puncture headache (PDPH) is a common problem after SA that occurs in 6%–36% of SA. We assessed the effect of four common treatment drugs sumatriptan, theophylline, pregabalin and oral caffeine on prevention of PDPH. In this systematic review, all randomized clinical trials (RCTs) during January 2015 and December 2021 were searched from PubMed, Google Scholar, Web of Science, Cochrane review and Clinical Key with a specific search strategy. The article qualities were assessed by two independent authors and were screened for relevant sources based on inclusion and exclusion criteria. Moreover, the included articles data were extracted and checked for regular basis. A total of 421 articles were identified and 193 articles were removed following a preliminary review and finally, 14 articles were included in review. Overall, we identified five RCTs on the effect of caffeine, two RCTs on the effect of sumatriptan, three RCTs on theophylline, three RCTs on pregabalin and one RCT on theophylline and sumatriptan in PDPH prevention. This review supports the effects of theophylline, pregabalin and sumatriptan in the prevention of PDPH incidence and treatment of PDPH intensity, but we cannot draw the same conclusions about caffeine due to some negative results about the caffeine effect. Nevertheless, this extracted conclusion should be considered and interpreted with caution and limited generalizations due to the small number of studies, the variety of evaluated drugs and measures, the low sample size and the bias presented.

Keywords: Caffeine, headache, pregabalin, review, spinal anaesthesia, sumatriptan, theophylline


How to cite this article:
Amini N, Modir H, Omidvar S, Kia MK, Pazoki S, Harorani M, Moradzadeh R, Derakhshani M. The effect of sumatriptan, theophylline, pregabalin and caffeine on prevention of headache caused by spinal anaesthesia (PDPH): A systematic review. J West Afr Coll Surg 2022;12:102-16

How to cite this URL:
Amini N, Modir H, Omidvar S, Kia MK, Pazoki S, Harorani M, Moradzadeh R, Derakhshani M. The effect of sumatriptan, theophylline, pregabalin and caffeine on prevention of headache caused by spinal anaesthesia (PDPH): A systematic review. J West Afr Coll Surg [serial online] 2022 [cited 2023 Feb 4];12:102-16. Available from: https://jwacs-jcoac.com/text.asp?2022/12/4/102/361846




  Introduction Top


Spinal anaesthesia (SA) for analgesia has more advantages than general anaesthesia during surgery.[1],[2],[3] In addition to being easy to administer, SA has rapid effects, relaxes muscles, and controls pain while performing surgery.[4],[5] SA is recommended for caesarean delivery[6] due to low risk of maternal pulmonary aspiration and foetal distress.[7] Nevertheless, SA has side effects such as neurological impairment, hypotension, decreased heart rate, nausea and vomiting, urinary retention, back pain, decreased ventilation and post-dural puncture headache (PDPH).[8],[9],[10],[11],[12]

PDPH is a common problem after SA and an unpleasant emotional experience.[8],[9],[13] A prevalence of 6 to 36% has been reported for PDPH following SA.[14],[15] Symptoms of PDPH appear a few hours after dura puncture and last up to 7 days (4–6 days).[4] PDPH can be associated with nausea, vomiting, neck stiffness, visual and auditory impairment, seizures, subdural haemorrhage, and rarely cerebral palsy[14],[16] The most common risk factors for PDPH include female gender, young age, pregnancy, previous headache history, low CSF pressure, and low body mass index.[14],[17],[18],[19],[20]

Many treatment protocol are available to prevent and reduce the PDPH[14],[21],[22],[23],[24] including cosintropin, aminophylline, dexamethasone,[13],[25],[26] fluid therapy and bed rest,[22],[27] epidural saline injection, intrathecal catheter insertion, epidural prophylactic blood patch,[28] performing special anaesthesia techniques[29] and the use of caffeine.[30],[31] However, the results of the studies are contradictory. Despite various treatments, PDPH is still an unwanted and annoying complication of SA.[21] Among the treatments, caffeine is a safe and effective option in the management of PDPH.[23],[31],[32],[33],[34] Oral and intravenous theophylline can be effectively treated PDPH, which inhibit the enzyme phosphodiesterase and increase the concentrations of cellular CAMP and antagonistic effects of adenosine receptors.[13] Pregabalin, is a anticonvulsant drug that prevents calcium from entering the body, therefore preventing headaches.[35] Sumatriptan, as a serotonin receptor agonist, effectively relieves migraines and cluster-type headaches.[36] However, different methods for PDPH prevention and treatment are suggested with conflicting results. The effectiveness of drugs used for PDPH was reviewed in 2015, but since then no systematic review or meta-analysis has been conducted, but several clinical trials on theophylline, pregabalin, sumatriptan and caffeine have been conducted. A systematic review of the clinical efficacy of these four drugs is needed in order to inspire future guidelines. Therefore, we aimed to evaluated the results of different treatment interventions of sumatriptan, theophylline, pregabalin, and oral caffeine on prevention of PDPH in a systematic review.


  Materials and Methods Top


In this systematic review, all randomized clinical trials (RCTs) during January 2015 and December 2021 in English-language. The inclusion criteria for RCTs were studies which considered the CONSORT form, human studies that the patients undergone lumbar puncture for SA, studies which the main outcome was headache after spinal, intervention included one or more of sumatriptan, pregabalin, theophylline, caffeine drugs and placebo or any other drug compared with the effect of the main interventions. In addition, study subjects were those who reported headaches following SA, either in the hospital or 5 days after surgery.[37] The exclusion criteria of the study were migraine history, other types of headaches, and other diseases.

The search was conducted in PubMed, Google Scholar, Web of Science, Cochrane review and Clinical Key with a specific search strategy related to sumatriptan, theophylline, pregabalin, caffeine, dural puncture, and spinal headache. Two authors (NA and HM) independently conducted the search in different databases and all sources were entered to EndNote software and duplicated sources removed. As a first step, unrelated and repetitive articles were screened among the found articles based on inclusion and exclusion criteria. To find other articles that may be related, reference lists of articles were manually searched. The titles and abstracts of the articles were reviewed independently by three researchers (two from anaesthesiology and one from the epidemiology department) and the full texts of the articles found to be relevant were then reviewed. Data were extracted by anaesthesiologists (NA and HM) who are the authors of this paper. A data collection form was used to extract clinical trial data for review on a regular basis. The article title, author names, years of publication, country of conducted study, sample size, age and sex of patients, types of study, and findings related to the variables under study.

The primary outcome in this review was headache after SA, myelogram, or diagnostic lumbar puncture that is a common complication caused by the puncture of the dura membrane.[38] In this study, a headache resulting from intentional tearing of the dura membrane in SA, occurring at the forehead or behind the head, aggravated by sitting or standing, and relieved partially or completely by sleeping, was considered. This headache is usually described as ambiguous or pulsating. associated symptoms are nausea and vomiting, anorexia, lethargy, neck pain, dizziness, tinnitus, hearing loss, vision problems such as double vision, blurred vision, photophobia, and paralysis of cranial nerves and seizures. Pain score and the severity of headache pain was measured in all included study by the visual analogue scale (VAS) scale. The VAS is commonly a 10-point scale was used with a score of 0 representing no pain and a score of 10 representing intolerable pain.[35],[39],[40] In addition, the patient, classification of headache severity was done as: No headache=0, mild headache<3, moderate headache 4–6 and severe headache >6.[41] Nevertheless, in some studies, a 5-point visual analogue pain scale was used to describe the intensity of pain. This scale varied from 0 = no pain, 1 = mild pain (pain which did not affect the everyday activity of patient), 2 = moderate pain (pain which was present on standing but relieved somewhat on lying down, confining them to bed), 3 = severe pain (pain which did not even relieve on lying down) and 4 = very severe pain (severe pain along with associated symptom, i.e., nausea, tinnitus, neck stiffness, etc.).[36],[42]

Quality of extracted articles (risk off bias of individual stories)

Cochrane checklist was used to evaluate the quality of the articles. Two anaesthesiologists and an epidemiologist assessed the quality of the articles. The risk of bias in the quality of articles has been evaluated and reported. Reporting was also conducted based on the Prisma checklist. A random sequence generation and allocation concealment evaluation was used to evaluate selection bias in the articles included in this regular review. To evaluate performance bias, blinding performed on participants in each study was investigated and reported. Each of the final articles was evaluated for blinding the outcome in order to find detection bias. To determine reporting bias in each study, incomplete or selective outcome reporting was examined. [Figure 1] shows the risk assessment of bias in the included studies.
Figure 1: Assessment of risk of bias in included studies

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Four common treatment interventions were assessed in this review for controlling the headache after SA. Caffeine is a methylxanthin that prevents sleepiness by blocking adenosine receptors, stimulating certain parts of the autonomic nervous system, and constricting cerebral vessels.[14]Theophylline tablet is one of the methylxanthines used in the treatment of asthma. It works by inhibiting the phosphodiesterase enzyme, increasing cell CAMP levels, and blocking the effects of adenosine receptors. This ultimately causes cerebrovascular contraction and can be effective in treating PDPH.[43]Pregabalin is one of the anticonvulsants that prevents calcium from entering the brain, thereby preventing headaches. It has also been used in patients with epilepsy, chronic pain, and anxiety disorders.[35]Sumatriptan is effective in relieving migraines and cluster headaches as a serotonin receptor agonist type 1. Among the most effective anti-migraine drugs, triptans have also been shown to be effective in managing PDPH. This drug is well tolerated and effective especially when combined with analgesics.[36]


  Results Top


A total of 421 articles were identified by searching PubMed, science direct, Google Scholar databases, and manual search references of article sources. As shown in [Figure 2], from all searched sources, 193 articles were removed following a preliminary review of their titles and abstracts. Among the remaining articles, 14 met the inclusion criteria and were included in this review.
Figure 2: Process of selected articles for the study

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Study specifications

[Table 1] shows the characteristics of included studies including the randomization, blinding, age group of participants, the method of PDPH diagnosis, intervention group treatment, control group treatment and the way of measuring of headache intensity as well as inclusion and exclusion criteria. In addition, descriptive statistics of patients and the pain score based on the VAS is presented in [Table 2].
Table 1: Characteristics of included studies

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Table 2: Descriptive statistics and the pain score (VAS) in different time after operation in included studies

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For each intervention group, the number of samples ranged from 20 to 102. Each article reported 0 to 3 dropped patients, with the Modir et al.’s[44] study reporting the most (n = 3, 6%) rate of dropout. In this study, participants ranged in age from 18 to 75 years with an average age of 30.98 years, and the majority of studies involved (female, n = 1232 and male, n = 337).

As shown in [Table 1], seven studies were conducted in Iran, four studies in Egypt, two studies in India, and one study in Turkey. This review identified 5 clinical trials on the effect of caffeine, 2 clinical trials on the effect of sumatriptan, 3 clinical trials on theophylline, 3 clinical trials on pregabalin, and 1 clinical trial on theophylline and sumatriptan in PDPH prevention. Several studies included patients who have been defined as first and second classification by the American Society of Anesthesiologists.[34],[35],[36],[40],[41],[44],[45],[46]

Treatment interventions

Caffeine effect

Seven different studies assessed the caffeine effect on PDPH. Modir et al. found that caffeine usage up to 3 days after surgery and melatonin usage up to 5 and 7 days after surgery significantly reduced postoperative headache scores.[44] In addition, in the Moshari et al. study, PDPH decreased in the group that consumed caffeine along with exercise compared to the control group.[41] Nevertheless, in Masoudifar et al. study no significant difference observed in pain reduction between caffeine users and placebo users.[34] moreover, the caffeine consumption combined with acetaminophen have less effect on PDPH treatment than mannitol in Shahriari et al. study.[45] In other studies, a comparison of caffeine with placebo has been used and showed that Caffeine (CAF) is associated with lower headache intensity and duration and decrease in PDPH incidence after SA.[34],[41],[44] Nevertheless, superior results of caffeine were not observed in one study.[45] In Shahriari et al. study[45] showed that IV mannitol infusion had faster and earlier effect for the treatment of PDPH than acetaminophen-caffeine capsule and is more effective for treatment of PDPH.

Pregabalin effect

According to Bhattacharya et al., pregabalin combined with paracetamol was a better treatment for PDPH than each of the drugs alone.[47] In EL-ghuoshy et al. study, pregabalin significantly reduced the incidence of PDPH in pregnant women.[46] In addition, pregabalin significantly reduced the mean score of pain in people undergoing elective caesarean sections.[35] In another study, pregabalin was compared with control group and showed that preoperative oral pregabalin before caesarean section reduced the incidence of PDPH.[46]

Sumatriptan effect

Botros et al. study found that sumatriptan intervention reduced pain in comparison control group (multivitamin).[36] The Ghenei et al. study showed that prophylactic Sumatriptan significantly decrease the incidence of postdural puncture headache during 48 h after induction of SA.[42]

Theophylline effect

Shaat et al.[40] compared theophylline with sumatriptan and showed Oral theophylline is more effective and safer than oral sumatriptan in control of PDPH.[40] Moreover, Mahoori et al. study showed that the pain score was significantly lower in theophylline group in comparison with the acetaminophen group and Theophylline is a safe and effective treatment for PDPH.[43] Based on Gholami et al. study, theophylline showed a greater reduction in VAS scores in PDPH than gabapentin.[24] In a study by Ergün et al. the mean of VAS after theophylline infusion was significantly lower than the control.[48] In the study of Salama et al., theophylline was compared with ergotamine and showed that adding either ergotamine or theophylline to paracetamol were more effective in decreasing intensity of PDPH pain than using paracetamol alone. Therefore, in comparing to ergotamine and paracetamol, theophylline is more effective due to lower pain score and better patient satisfaction.[39] Moreover, in Gholami et al. study, theophylline is compared with gabapentin and showed that both gabapentin and theophylline are effective against PDPH, but theophylline was more effective for pain relief than gabapentin.[24] In another study, a significant pain reduction was observed in patients who received theophylline, but the study lacked a control group, therefore, the results could not be considered correctly based on the methodological structure of the study.[48]

Bias resources

Based on inclusion criteria, the studies included in this systematic review are highly heterogeneous and have several sources of bias. As can be seen in [Table 1], there are differences between studies in terms of age distribution and inclusion and exclusion criteria. Moreover, the placebo was varied in different studies. In addition, the onset of treatment, drug doses, and prescription times were varied in a large number of studies. The majority of studies have been conducted on women,[35],[36],[45],[46],[47] so selection bias may limit generalization to men. Moreover, the range of outcome assessment time has varied greatly from zero time to 168 h. In two studies, numerical rating scale (NRS)[39] and 5-point verbal rating scale[42] was used, while the VAS was used to measure headache severity in other studies. In a number of studies[35],[39],[41],[46],[48] the validity of double blinding is uncertain or ambiguous, and one study[45] used single blinding. Therefore, a risk of bias can be considered in terms of quality of bias. In some studies, the randomization method is not explained in detail, and in a large number of studies[36],[39],[42],[44],[46],[48] the randomization method was unknown. In most studies, attrition was high. Although, in the most studies the risk of bias was low and had minimal reporting bias.


  Discussion Top


This systematic review investigated the effects of oral caffeine, sumatriptan, theophylline, and pregabalin on preventing post-SA headaches. We assessed the effect of four common treatment drugs and concluded on their effect on PDPH incidence, intensity and duration. According to the studies, two mechanisms have been suggested as the causes of PDPH. One of the mechanisms is rupture of the dura mater membrane and loss of cerebrospinal fluid and stretching of pain-sensitive structures inside the skull. Another mechanism is the reduction of intracranial pressure and dilation of cerebral arteries.[38] Although, there is evidence that dilation of arterial blood vessels in the cerebral circulation greatly contributes to headaches as PDPH. Activation of serotonin in cerebral arteries leads to vasoconstriction and may neutralize this effect.[49],[50] Caffeine reduces cerebral blood flow by blocking adenosine receptors, which increases contractility of cerebral arteries. In addition, caffeine increases CSF production by activating the sodium potassium pump.[14],[51]

Some studies have recommended caffeine as a treatment option for PDPH since caffeine was first used as a therapeutic agent in 1949.[51],[52] In Masoudifar et al.[34] and Modir et al[44] studies, the combination of acetaminophen plus caffeine and dexamethasone reduced pain intensity, pain duration, and PDPH incidence.[34],[44] Nevertheless, negative results[45] regarding caffeine effect has been reported. The Gupta study, showed that pain scores decreased less in patients receiving the combination of paracetamol and caffeine in comparison to prednisolone.[37] Matthews and Wilson demonstrated that benzoate caffeine decreases cerebral blood flow after intravenous administration for the treatment of PDPH by blocking adenosine receptors.[8] In another study, the incidence of PDPH in the caffeine and combined exercise groups was lower than in the group receiving a placebo, the headache was more severe in the control group and the need to receive analgesics in the control group was reported to be higher than caffeine group.[41] In another study, intravenous mannitol had a greater reduction in pain scores than the group receiving acetaminophen-caffeine capsules and was more effective than that.[45] A recent review examined 13 low-volume RCTs with 479 participants to examine whether caffeine, sumatriptan, gabapentin, pregabalin, theophylline, hydrocortisone, Cosintropin, and intramuscular adrenocorticotropic hormone (ACTH) could reduce the incidence of PDPH within 1–2 h when compared to a placebo. In this review, it was shown that caffeine can reduce the incidence of PDPH within 1–2 h when compared with a placebo.[21],[23] Caffeine therapy also reduced the need for conservative supplemental treatment options, whereas in our review caffeine was able to lower pain scores and reduce the incidence of PDPH in only two studies compared to the placebo group.

The serotonin receptor antagonist sumatriptan, used to treat migraines, has been linked to PDPH relief in limited cases.[53] A study showed that sumatriptan was more effective in PDPH treatment than the group receiving naratriptan 6 and 12 h after SA, but for the rest of the time, this effect was not noticeable.[36] In the study by Ghanei et al. Sumatriptan prophylaxis was significantly more effective in reducing the incidence of PDPH than the placebo receiving group.[13] In a review[21] Sumatriptan showed no effect in reducing the incidence of PDPH, whereas in our study sumatriptan prophylaxis was significantly effective for this purpose.

Theophylline is a methyl xanthine that contracts cerebral vessels and improves pain intensity compared to placebo in randomized studies.[53] In the study by Ergun et al. Theophylline infusion had a rapid and significant effect on reducing pain score.[48] In the study by Gholami et al. within 24 h after the intervention, the group receiving theophylline reported lower pain scores than gabapentin, but there was no significant difference between the pain scores of the two groups before the intervention and 8 and 16 h after the intervention.[24] Compared to ergotamine and paracetamol, theophylline significantly decreased NRS, the duration of pain relief was shorter and patient satisfaction was higher.[39] In the study by Shaat et al. Theophylline was safer and more effective than sumatriptan in the treatment of PDPH, demonstrated lower NRS scores, shorter PDPH duration, and fewer side effects.[40] In a review,[21] treatment with theophylline showed lower VAS scores compared to acetaminophen in 2, 6 and 12 h. It also showed lower VAS scores compared to conservative treatment at 8, 16, and 24 h later. There was also a reduction in pain with theophylline compared to placebo. Theophylline improved pain in a significantly higher proportion of participants than conservative therapy. In all studies, theophylline decreased pain levels significantly. Also, when compared with sumatriptan, theophylline was safer and more effective in the treatment of PDPH.

Pregabalin is an anticonvulsant drug that prevents calcium from entering the brain. This drug is effective in preventing headaches and has been used for treating epilepsy and chronic pain. Pregabalin also improves anxiety disorders. Few studies have examined the effect of pregabalin on PDPH.[26] Pregabalin significantly reduced pain scores in the study by El-Gusoshy et al.[46] A combination of pregabalin and paracetamol was studied by Bhattacharya et al, the combination significantly reduced pain scores compared to either drug alone.[47] According to the study, PDPH severity and incidence may be reduced by using pregabalin the night before SA compared to a placebo.[35] In one review, pregabalin did not show a significant effect,[21] whereas in our review pregabalin showed a significant reduction in pain scores compared to placebo.

Limitations of our study:

In some studies, included in this review, in addition to the main intervention, other interventions including the use of diclofenac[40] and exercise,[41] and caffeine combined with acetaminophen may affect the evaluation of the main intervention.[41] Therefore, there was a possibility of bias in our results and we cannot do meta-analysis due to heterogeneity included studies. In addition, a limited number of studies (RCTs), small sample size, low variety of evaluated drugs, limited generalization of findings due to the low number of included studies. Therefore, future studies suggesting among trials with larger samples and long-term follow-up periods.


  Conclusion Top


This review supports the effects of theophylline, pregabalin, and sumatriptan in the prevention of PDPH incidence and treatment of PDPH intensity, but we can’t draw the same conclusions about caffeine due to no superior results about the caffeine effect. Nevertheless, this extracted conclusion should be considered and interpreted with caution and limited generalizations due to the small number of studies, the variety of evaluated drugs and measures, the low sample size and the bias presented.

Acknowledgement

We would like to extend a special debt of gratitude to the Valiasr Hospital’s clinical research council for its assistance and guidance and to thank the research deputy of Arak University of Medical Sciences for his contributions throughout the development of this study.

Financial support and sponsorship

This study was supported by Arak University of Medical Sciences.

Conflicts of interest

There are no conflicts of interest.



 
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